The regulator's opinion provides the basis for the European Commission’s final decision.
Credit: iStock Photo
Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union's drug regulator for their drug Filspari, part of an industry race to treat a rare, serious kidney condition known as IgAN.
The regulator's opinion provides the basis for the European Commission’s final decision, Vifor said in a statement.
The pharma companies are competing to develop treatments for IgAN, which is a progressive autoimmune disease that mostly affects young adults, and which can lead to kidney failure that requires dialysis or organ transplantation.
Novartis last year acquired US biotech firm Chinook for up to $3.5 billion to bolster its work on therapies.
Travere in early 2023 won accelerated approval from the US Food and Drug Administration for Filspari, or sparsentan, to treat IgAN. Travere said in December it would be seeking full US approval.
Vifor Pharma owns exclusive commercialization rights for sparsentan in Europe and other markets.
Calliditas Therapeutics' IgAN drug Tarpeyo won full US approval in December 2023.
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