2021-01-25| Trials & Approvals

FDA Approves Second Lupus Nephritis Drug in Two Months

by Rajaneesh K. Gopinath
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Just a month after approving GSK’s Benlysta (belimumab), the FDA has now approved a second drug for treating lupus nephritis. On January 22nd, Candian biotech Aurinia Pharmaceuticals Inc. bagged the agency’s authorization for its immunosuppressant drug, Lupkynis (voclosporin).

“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. 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.

“The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS.”

Lupkynis is the company’s first product to get regulatory approval. In light of the news, Aurinia’s stocks climbed from Friday’s closing price of $14.90 to $20.46 on Monday.


Lupkynis – First Oral Therapy for Lupus Nephritis

Lupus is a potentially fatal disease that affects about 200,000 people in the US. It is an autoimmune disease where the body’s immune system starts attacking normal cells and tissues, causing organ damage. Treatment is challenging for this condition because it is unpredictable with unknown causes. Lupus nephritis is characterized by the inflammation of the kidney and is one of the serious complications of Systemic Lupus Erythematosus.

By binding to the signaling protein calcineurin, Lupkynis blocks T cell activation and prevents autoimmune responses. The drug registered positive data in the Phase 3 AURORA trial and Phase 2 AURA-LV trial, where it outperformed the standard of care (soc). Specifically, Lupkynis plus soc treated patients demonstrated a statistically significant higher Renal Response rate of 43.7% vs. 23.3% for soc plus placebo arm at one year.


“Momentous” Approval

Lupkynis is now the first-ever oral therapy for lupus nephritis to be FDA authorized. Earlier, it also received the priority review and fast track designations from the agency. The approval brought high praise from various organizations such as the Lupus Foundation of America and the Lupus Research Alliance. Experts in the lupus community gladly welcomed the availability of two new treatment options for a once hard-to-treat disease.

“A new treatment option to fight lupus nephritis, one of the most devastating impacts of lupus, is a significant moment to celebrate,” said Stevan W. Gibson, president, and CEO, Lupus Foundation of America. “For a long time, there were no approved treatments for this potentially disabling and life-threatening complication of lupus. We are thrilled that doctors now have a second new option to treat lupus nephritis, which affects up to 60% of people with lupus.”

The global market for lupus drugs is estimated to touch $3 billion by 2027. When GSK’s benlysta received its first approval in 2011, it was the first treatment for lupus in 50 years. Over the years, it has added key approvals, one for SLE in 2017 and lupus nephritis in 2020. However, Aurinia reports that Lupkynis treatment has delivered results in lupus nephritis patients in one year that benlysta achieved in two. Therefore, one could expect the drug to hold a competitive edge in the longer term. With several other players, including AstraZeneca, Biogen, Alpine Immune Sciences, and Celgene/BMS currently developing drugs for SLE, it would be interesting to watch the developments in this therapeutic area.

Related Article: AbbVie Nabs Exclusive Worldwide Option for Alpine’s CD28/ICOS Dual Inhibitor



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