FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes

pharmafile | August 20, 2020 | News story | Research and Development, Sales and Marketing FDA, Gilead, filgotinib 

Gilead’s JAK inhibitor filgotinib has been unexpectedly knocked back by the FDA as a therapy to treat moderately to severely active rheumatoid arthritis (RA), jeopardising the company’s ability to secure approval before the end of this year.

In a Complete Response Letter (CRL) sent to Gilead in response to its New Drug Application, the US regulator asked for additional data from two clinical studies due to concerns over the benefit/risk profile of the medication when administered in a 200mg dose. Topline data from the two studies are expected to land in the first half of next year.

The development of filgotinib is the product of a partnership between Gilead and Galapagos. Because the necessary data will not be available until 2021, it is expected that Gilead will be unable to push through a regulatory approval before the end of the year. Galapagos is eligible to receive a milestone payment of $100 million on US approval of the drug, but this knockback has led the company to alter its 2020 operational expense guidance to between €490 million and €520 million.

“We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” remarked Merdad Parsey, Gilead’s Chief Medical Officer. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical programme.”

It is expected that the earliest that Gilead would be able to secure approval would be 2022, meaning it would trail behind other rival JAK inhibitors in hitting the market. 

Matt Fellows

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