voclosporin fda label

“The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. x�ӏ0Pp�� endstream endobj 610 0 obj <>stream %%EOF “The approved label supports the efficacy and safety of Lupkynis as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background … x��r FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis – LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a … UPCR is a standard measurement used to monitor protein levels in the kidney. �V��)g�B�0�i�W��8#�8wթ��8_�٥ʨQ��Q�j@�&�A)/��g�>'K�� t�;\�� ӥ$պF�ZUn��(4T�%)뫔�0C&��Z��i��8��bx��E��B�;��P��ӓ̹�A�om?�W= Mild and Moderate Hepatic Impairment: Reduce Lupkynis dose. Limitations of Use: Safety and efficacy of Lupkynis have not been established in combination with cyclophosphamide. %PDF-1.6 %�� Increased … The US Food and Drug Administration (FDA) announced January 22 that it has approved Lupkynis (voclosporin) for treatment of active lupus nephritis (LN) among adult patients, in combination with a background immunosuppressive therapy regimen. "�'T]rs��ar'u{�N7�v��L��v 7��ۅ�3�R��s��Y��r-�pt�.�x��g)Nj��O��nW��Ks��7��v��wU�i:��3H;�֢�p��v>[˙0��I��8zB��vg�DV��)��O�L�x Introduction to Medical Device Labeling Label vs. Labeling. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. To learn more about Aurinia Alliance or Lupkynis, visit www.LUPKYNIS.com. BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS. VICTORIA, British Columbia & ROCKVILLE, Md.-- January 22, 2021 -- Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate. The studies enrolled patients with LN of Class III or IV (alone or in combination with Class V) or pure Class V. Enrolled patients were required to have baseline eGFR >45 mL/min/1.73 m2. To learn more visit www.auriniapharma.com. Patients treated with Lupkynis showed improved response rates in all parameters across immunologically-active classes of LN studied. On January 22, the FDA approved Voclosporin to treat Lupus Nephritis. Summary. (*��(%�8H��8c�-�� f�ԉd�9�@6_IjH��9��(3=�D��R�1%? ... You may report side effects to FDA at 1-800-FDA-1088. FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis. Neurotoxicity: Lupkynis, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions. Such risks, uncertainties and other factors include, among others, the following difficulties we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; the results from our clinical studies and from third party studies and reports may not be accurate; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Do not use in larger or smaller amounts or for longer than recommended. 758 0 obj <>stream Reduce Lupkynis dosage when co-administered with moderate CYP3A4 inhibitors. Aurinia Pharmaceuticals, a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin… n�3ܣ�k�Gݯz=��[=��=�B�0FX'�+��t��G�,�}��/��Hh8�m�W�2p[��AiA��N�#8$X�?�A�KHI�{!7�. Aurinia Releases Open-Label AURION Data Demonstrating Increased Remission Rates Over Time for Voclosporin in the Treatment of Lupus Nephritis Aurinia Pharmaceut Lupkynis is now available to patients in the United States (U.S.). Lymphoma and Other Malignancies: Immunosuppressants, including Lupkynis, increase the risk of developing lymphomas and other malignancies, particularly of the skin. K�� Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent. x�+� � | 0 The disposition of cyclosporine from blood is generally biphasic, with a terminal half-life of … Voclosporin, a calcineurin-inhibitor immunosuppressant, is the first oral therapy approved by the FDA to treat adults with SLE and active lupus nephritis. �ꇆ��n��Q�t�}MA�0�al��S�x ��k�&�^��>�0|>_�'��,�G! The use of Lupkynis in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation. The approval of Lupkynis is based on data from Aurinia’s pioneering late-stage global clinical studies in LN – the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). FDA Home - IMPORTANT DISCLAIMER. "The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia's proprietary and patented eGFR pharmacodynamic dosing protocol. N'��)�].�u�J�r� These FDA Food Labeling web pages address the labeling requirements for foods under the Federal Food, Drug, and Cosmetic Act and its amendments. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals. The Lupus Research Alliance is pleased to share an announcement from Aurinia Pharmaceuticals that moves its potential treatment for lupus nephritis, voclosporin, one step closer to approval by the U.S. Food and Drug Administration … I discuss the condition lupus nephritis in the context of Aurinia Pharmaceutical's (AUPH) recent FDA approval for their medication voclosporin (lupkynis). The dose of voclosporin for Cohort 2 (at least 10 subjects) will be … "F$H:R��!z��F�Qd?r9�\A&�G��rQ��h��E��]�a�4z�Bg��E#H �*B=��0H�I��p�p�0MxJ$�D1��D, V��ĭ��KĻ�Y�dE�"E��I2��E�B�G��t�4MzN��r!YK� ��?%_&�#��(��0J:EAi��Q�(�()ӔWT6U@��P+��!�~��m��D�e�Դ�!��h�Ӧh/��']B/��ҏӿ�?a0n�hF!��X��8��܌k�c&5S��6�l��Ia�2c�K�M�A�!�E�#��ƒ�d�V��(�k��e��l ��}�}�C�q�9 2y�.-;!��K�Z� ��^�i�"L��0��-�� @8(��r�;q��7�L��y��&�Q��q�4�j��|�9�� Select one or more newsletters to continue. LUPKYNIS (voclosporin) capsules, for oral use Initial U.S. Approval: 2021 WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; the accuracy of reported data from third party studies and reports; that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third parties. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids. QTc Prolongation: Lupkynis prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally. If PRCA is diagnosed, consider discontinuation of Lupkynis. Physician reviewed voclosporin patient information - includes voclosporin description, dosage and directions. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS TM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). 1. It is possible that such results or conclusions may change based on further analyses of these data. • Label with dosing data likely extends IP runway due to 2037 patent. “It is encouraging that Fast Track designation has been granted for voclosporin and we look forward to working closely with FDA … The study results were achieved using a protocol-defined steroid taper. Voclosporin … We are thrilled to bring Lupkynis to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. Lupus Foundation of America Congratulates Aurinia Pharmaceuticals on FDA Approval of Lupkynis™ (voclosporin) to Treat Lupus Nephritis PRESS RELEASE PR Newswire Jan. 23, 2021, 03:12 AM Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered. Voclosporin, the first FDA-approved oral therapy for this condition, has shown significantly improved renal response rates when compared with standard therapies. h�bbd```b``� �N �I D2�EB�d#X\DrE!��_�U��9�dn��~v`qM�� 6lK,�4F� �jU��hi~ ��$��6 �� v�(9JR�d�;��K� 1p� Patients treated with Lupkynis showed improved response rates in all parameters across immunologically-active classes of LN studied. Lupkynis™ (voclosporin) was approved by the U.S. Food and Drug Administration (FDA) to treat adults with lupus nephritis in January, 2021. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia’s estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. After nearly two and a half decades, Aurinia Pharmaceuticals' immunosuppressant voclosporin finally garnered FDA approval last week. Pregnancy/Lactation: May cause fetal harm. Serious Infections: Immunosuppressants, including Lupkynis, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes. The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Importantly, the FDA product label incorporated a US patent related to the eGFR dosing used in Aurinia's AURA and AURORA trials, potentially extending exclusivity through 2037. Lupkynis was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. The NDA for voclosporin is supported by data from a substantial global clinical program including two pivotal … A label was included with a personal dosage protocol, which implies that VC will be protected against generics … Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox. ��8�׫��A&��с��*@@a ~[�%�|��0�Lf`K��@�NE�׀4+�!�e..V�w��1��c��i��c��*�Y�#�x�o��0l��c��8�A v��72�ebaYK��mҌ@�` �.� Voclosporin has been approved in combination with a background immunosuppressive therapy regimen. �x��- ��[�� 0��}��y)7ta��>j��T�7��@��tܛ�`q�2��ʀ��&��6�Z�L�Ą?�_��yxg)˔z��çL�U��*�u�Sk�Se�O4?׸�c��.� � �� R� ߁��-��2�5�� S�>ӣV��d�`r��n~��Y�&�+`��;�A4�� A9� =�-�t��l�`;��~p�� Gp| ��[`L��`� "A�YA�+��Cb(��R�,� *�T�2B-� endstream endobj 609 0 obj <>stream Aurinia Moves Voclosporin Closer to FDA Approval for Lupus Nephritis. Lupkynis (Voclosporin Capsules) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health … In the Phase 3 study, at one year, Lupkynis plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Voclosporin softgel capsules. H��yTSw�oɞ��c [��5la�QIBH�ADED��2�mtFOE�.�c��}��0��8�׎�8G�Ng��9�w��߽�� '��0 �֠�J��b� In animal reproductive studies, oral administration of either voclosporin or a 50:50 mixture of voclosporin and its cis-isomer was embryocidal and fetocidal in rats and rabbits at doses 15- and 1-times, respectively, the maximum recommended human dose (MRHD) of 23.7 mg twice a day, based on drug … ��w3T�PI�24P ��.��ԴԢԼ�TO+scSc#M��,.�. Voclosporin was also granted Fast Track designation by the FDA in 2016. Oral administration of either voclosporin or a 50:50 mixture of voclosporin and its cis-isomer was embryocidal and feticidal in rats and rabbits at doses 15x and 1x, respectively, the maximum recommended human dose (MRHD) of 23.7 mg BID, based on drug … Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Drug labeling on this Web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include strengthened warnings undergoing FDA review and minor editorial changes. All forward-looking information contained in this presentation is qualified by this cautionary statement. endstream endobj startxref “The Lupkynis approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. I share with you insight on Aurinia Pharmaceuticals (AUPH). Lupkynis™ (voclosporin): What you need to know. The approval, representing the first FDA-approved oral therapy for lupus nephritis, allows Aurinia Pharmaceuticals to move forward with the treatment in combination with a background immunosuppressive therapy regiment for adult patients. “There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, Lupkynis (voclosporin) FDA Approval History. Severe renal impairment: Reduce Lupkynis dose. Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). INDICATION AND IMPORTANT SAFETY INFORMATION. About Voclosporin. Also, many of the factors are beyond our control. Follow all directions on your prescription label and read all medication guides or instruction sheets. Lupkynis is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite. Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. FDA Approves First Oral Medication for Lupus Nephritis. ... (voclosporin), the first FDA … � �T��Op��zf?�m��cVw�sA _4��jw��Y�n1��a�v``H8#�G�mɌػ�p��9�g�r-.�U��Sc��b^��Ei. The starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg. LUPKYNIS is the first FDA … Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. endstream endobj 605 0 obj <> endobj 606 0 obj <> endobj 607 0 obj <>stream 31, 64 Advagraf was not approved by the FDA in the United States. All patients were dosed with concurrent MMF at a target dose 2 g/day. "The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. Voclosporin works by blocking calcineurin, a substance related to inflammation. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. VICTORIA, British Columbia-- Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for voclosporin, the Company’s next generation calcineurin inhibitor, for the treatment of Lupus Nephritis (LN). LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. endstream endobj 611 0 obj <>stream What's new in food labeling and nutrition, including label claims, nutrition labeling for restaurants, and links to industry guidance. We comply with the HONcode standard for trustworthy health information -, Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis, Lux Biosciences Receives Complete Response Letter from FDA for Luveniq, FDA cancels advisory committee meeting for voclosporin - Priority review of Lux Biosciences ' NDA continues, FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq, Lux Biosciences' Luveniq Receives FDA Priority Review, Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis. … Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.”, “Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. “The FDA approval of Lupkynis allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”. Nephrotoxicity: Lupkynis, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. Lupkynis is the first FDA-approved oral therapy for LN. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with Lupkynis. Voclosporin (ISA 247) is a calcineurin inhibitor intended for use in the treatment of psoriasis, prevention of organ rejection after transplantation, and the management of autoimmune diseases (uveitis, … January 22, 2021 - 8:24 pm. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Immunizations: Avoid the use of live attenuated vaccines during treatment with Lupkynis. Voclosporin (ISA 247) ... studies reporting a systematic 10–20% lower AUC 0–24 in comparison to Tac-BID. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 633 0 obj <>/Filter/FlateDecode/ID[<1C983B1F2D30B6438FC823C9BF98420D><4BBAD1D46C5FCE4DB3CEB61A6262A378>]/Index[604 155]/Info 603 0 R/Length 142/Prev 504280/Root 605 0 R/Size 759/Type/XRef/W[1 3 1]>>stream Severe hepatic impairment: Avoid Lupkynis use. WASHINGTON, Jan. 22, 2021 /PRNewswire/ -- For the second time in less than two months, the U.S. Food and Drug Administration (FDA) has approved a new medication to treat adults with lupus nephritis (lupus-related kidney disease) in combination with a background immunosuppressive therapy regimen. cyclosporine is primarily biliary with only 6% of the dose (parent drug and metabolites) excreted in urine. Once patients progress to LN, they face inevitable life-altering effects,” said Kenneth M. Farber, President and CEO, Lupus Research Alliance. This news follows the FDA-approval of belimumab (Benlysta) for lupus nephritis in December 2020, when it became first drug ever to be approved specifically for lupus nephritis. The FDA approval was granted for Aurinia’s Lupkynis oral therapy to be used in combination with an immunosuppressive therapy regimen. FDA Online Label Repository. VICTORIA, British Columbia & ROCKVILLE, Md.-- January 22, 2021 -- Aurinia Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). FDA Approves Aurinia Pharmaceuticals’ LUPKYNIS™ (voclosporin) for Adult Patients with Active Lupus Nephritis PRESS RELEASE Businesswire Jan. 23, 2021, 02:24 AM Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices. Drug-Drug Interactions: Avoid co-administration of Lupkynis and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Hypertension: Hypertension is a common adverse reaction of Lupkynis therapy and may require antihypertensive therapy. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. Please be aware of the following when using information from this Web site: The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label. These studies together demonstrated the ability of Lupkynis treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil (MMF), and low dose steroids. Please see Prescribing Information, including Boxed Warning, and Medication Guide for Lupkynis. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity. 2006-07-28. An existing patent and added exclusivity give voclosporin exclusivity to late 2027. To assist Lupkynis patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance™, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient’s Lupkynis treatment journey. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color.”. Although many rheumatologists already had off-label experience with Benlysta in LN, ... but I do think that over time you will see voclosporin taking a higher percentage of the share of all stable use of calcineurin inhibitors.” H�b``��$��WR��~��|@��T��#��2S/`M. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of Lupkynis.”, “For years treating patients with lupus nephritis has been challenging. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID). Today, Aurinia Pharmaceuticals announced they received authorization from the FDA to … Lupkynis is the first FDA-approved oral therapy for LN. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16. The US Food and Drug Administration (FDA) has approved voclosporin (LUPKYNIS) to treat patients with active lupus nephritis.. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia. Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) ("Aurinia" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS TM … FDA Approves Lupkynis (voclosporin) for Adult Patients with Active Lupus Nephritis. March 16, 2020. It marks the first FDA-approved oral therapy for LN, which causes irreversible kidney damage and raises the risk of kidney failure, cardiac issues, and death. Currently, 200,000-300,000 people in the United States are living with LN, a serious complication of systemic lupus erythematosus (SLE), with the disease disproportionately affecting Black, Asian, and Hispanic individuals.
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