Aurinia Pharmaceuticals Inc. ( AUPH Quick Quote AUPH - Free Report) announced that the FDA has approved its new drug application (“NDA”) for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen. The NDA sought approval for oral administration of the drug as treatment for adult patients with active lupus nephritis (“LN”). The drug is now the first and only FDA-approved therapy for treating LN.
The company has made the drug commercially available in the United States. It is also the first drug in the company’s commercial portfolio.
Please note that LN leads to irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is also one of the most serious and common complications in patients suffering from the autoimmune disease systemic lupus erythematosus.
Shares of Aurinia have lost 19.1% in the past year against the
industry’s rise of 3.4%.
The NDA for Lupkynis was approved based on promising data from pivotal studies evaluating the drug in combination with standard-of-care (SoC). Data showed that patients receiving Lupkynis in addition to SoC were more than twice as likely to achieve renal response compared to SoC alone. Moreover, the Lupkynis combo also reduced urine protein creatinine ratio twice as fast versus SoC alone.
Treatment for LN is challenging with a limited number of therapeutic options available. The approval to Lupkynis provides a new therapeutic option, which is a rapid-acting therapy and requires far less steroids. We expect Lupkynis approval to be encouraging for the company as it will likely create a steady stream of revenues for it. However, the impact of COVID-19 on the launch uptake of the drug remains to be seen.
Meanwhile, Aurinia inked an agreement with Japan-based Otsuka Pharmaceutical last year for the development and commercialization of voclosporin in Europe, Japan and a few other countries as a treatment for LN. A marketing authorization application is expected to be filed in the second quarter of 2021 in Europe seeking approval for voclosporin of LN patients.
A phase II/III study evaluating Lupkynis evaluating voclosporin ophthalmic solution for the potential treatment of dry eye syndrome, a chronic autoimmune disorder, failed to meet the primary endpoint in November 2020. The company plans to suspend the development of voclosporin in this indication.
Zacks Rank & Stocks to Consider
Aurinia currently carries a Zacks Rank #5 (Sell).
Some better-ranked stocks from the same sector include
Radius Health ( RDUS Quick Quote RDUS - Free Report) , Grifols ( GRFS Quick Quote GRFS - Free Report) and Organogenesis ( ORGO Quick Quote ORGO - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
Radius Health’s loss per share estimates have narrowed from $1.65 to $1.05 for 2021 over the past 60 days. Shares of the company have increased 16.9% in the past year.
Grifols’ earnings per share estimates have increased from $1.49 to $1.51 for 2021 over the past 60 days.
Organogenesis’ loss per share estimates have narrowed from 4 cents to 1 cent for 2021 over the past 60 days. In the past year, shares of the company have gained 126.3%.
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