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2022-09-20| Trials & Approvals

Aurinia Wins Approval For Lupus Nephritis Therapy In Europe

by Joy Lin
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Canada-based Aurinia Pharmaceuticals has won marketing approval in Europe for Lupkynis (voclosporin) to treat active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). 

The EU approval follows an approval from the US FDA for the drug last January, making Lupkynis the first oral medicine to gain approval for active LN in both the US and EU. 

Treating A Serious Kidney Complication 

LN is a serious kidney complication of SLE, a chronic autoimmune disease. Around 200,000 to 300,000 people live with SLE in the US, half of which may develop LN. Treatments for lupus and its complications include corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, and immunosuppressants. 

Lupkynis is a calcineurin inhibitor (CNI) with a dual mechanism of action. It acts as an immunosuppressant by inhibiting T-cell activation and cytokine production, and promotes podocyte stability in the kidney. 

The EC approval of Lupkynis is based on results from its pivotal Phase 3 Aurora 1 study and the Aurora 2 continuation study. The studies showed that Lupkynis, combined with first-line treatment of mycophenolate mofetil (MMF) and low-dose corticosteroids, led to superior complete renal response rates at 52 weeks compared to MMF and corticosteroids alone. The safety profile for both the experimental and placebo groups was also comparable. 

Like other CNI-immunosuppressants, Lupkynis comes with a Boxed Warning for increased risk for developing serious infections. 

Approval Triggers Milestone Payment From Partner Otsuka 

Lupkynis’ approval in Europe triggered a $30 million milestone payment from Aurinia’s partner Otsuka. The two companies’ collaboration over Lupkynis began in December 2020, giving Otsuka rights to develop and market the drug in the EU and Japan as well as other countries such as the UK and Russia. 

Sales of Lupkynis are expected to grow following the EU approval. According to Aurinia’s financial report for Q2 2022, the net revenue of Lupkynis was $28.2 million for the quarter ended on June 30, 2022, compared to $6.6 million for the same period last year. 

 

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