Galapagos NV (NASDAQ:GLPG) reports that collaboration partner and licensee Gilead Sciences (NASDAQ:GILD) received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of filgotinib for the treatment of moderate-to-severe rheumatoid arthritis (RA).
The CRL cited the need for data from the MANTA and MANTA-RAy trials, designed to assess filgotinib’s effect on sperm parameters, before completing its review. Topline results from both studies should be available in H1 2021.
The review team also expressed concerns with the benefit/risk profile of the 200 mg dose.
Gilead CMO Merdad Parsey, M.D., Ph.D., says, “We are disappointed in this outcome and will evaluate 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 2020 cash consumption guidance to €520M from €490M as a result.
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