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Gilead Gives Up On Galapagos's Filgotinib In RA

Belgian Biotech's Stock Battered

 
• By Kevin Grogan

A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.

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Gilead throws the towel in for filgotinib in RA • Source: Shutterstock

Shares in Galapagos NV have taken a pummelling on the news that partner Gilead Sciences, Inc. has all but thrown in the towel on filgotinib and abandoned plans to seek US approval for the JAK inhibitor in rheumatoid arthritis following a meeting with regulators.

Gilead has decided not to pursue approval of filgotinib (marketed in Europe as Jyseleca) after a type A meeting with the US Food and Drug Administration to discuss the points raised in a complete response letter in August when the agency surprisingly rejected the drug for RA

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