Lupkynis granted approval in Europe for lupus nephritis

The European Commission (EC) has granted marketing authorization of Lupkynis (voclosporin) to treat adults with active lupus nephritis (LN). This follows the positive European Medicines Agency’s CHMP opinion announced in late July, Canada-based Aurinia Pharmaceuticals (Nasdaq: AUPH) has revealed.

Aurinia has a collaboration and license agreement with Japan’s Otsuka Pharmaceuticals (TYO: 4578) for the development and commercialization of Lupkynis in the European Union, Japan, as well as several other ex-US territories. Lupkynis will compete with UK pharma major GSK’s (LSE: GSK) Benlysta (belimumab).

Under the agreement, Aurinia received an upfront cash payment of $50 million for the license agreement and has the potential to receive up to $50 million in additional regulatory and reimbursement milestones. The company will also receive tiered royalties on future sales ranging from 10%-20%. The approval by the EC triggered a $30 million milestone payment to Aurinia, which will be recognized as revenue in third-quarter 2022.