With US path uncertain, Gilead hands back Jyseleca rights

16 December 2020

An amended collaboration agreement will see Gilead Sciences (Nasdaq: GILD) hand back certain rights to Jyseleca (filgotinib), following discouraging feedback from the US regulator.

Gilead has been working with Belgian firm Galapagos (Euronext: GLPG) on the commercialization and development of Jyseleca, which has been approved in Japan and Europe as a treatment for rheumatoid arthritis.

The firms were dealt a hammerblow in August, when the US Food and Drug Administration issued a complete response letter (CRL) for a submission in this indication.

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