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Galapagos NV (NASDAQ: GLPG) reports that Gilead Sciences, Collaborative Partner and Licensee (NASDAQ: GILD) has received a Full Response Letter (CRL) from the FDA regarding its marketing application for approval of filgotinib for the treatment of moderate to severe rheumatoid arthritis (RA).
The CRL spoke of the need for data from the MANTA and MANTA-RAy trials, designed to assess the effect of filgotinib on sperm parameters, before completing their review. The main results of the two studies should be available in the first half of 2021.
The review team also expressed concerns about the benefit / risk profile of the 200 mg dose.
Gilead CMO Merdad Parsey, MD, Ph.D., said, “We are disappointed with this result and will assess the points raised in the CRL for discussion with the FDA. We continue to believe in the benefit / risk profile of filgotinib in RA, which has been demonstrated in the FINCH phase 3 clinical program. “
Galapagos has revised its cash consumption forecast for 2020 to € 520m, from € 490m as a result.
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