Galapagos NV (NASDAQ: GLPG) reports that collaboration partner and licensee Gilead Sciences (NASDAQ: VALID) received a Full 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 mentioned the need for data from the MANTA and MANTA-RAy trials, designed to assess the effect of filgotinib on sperm parameters before completing its evaluation. Topline results of both studies would be available in H1 2021.
The review team also raised concerns about the benefit / risk profile of the 200 mg dose.
Gilead CMO Merdad Parsey, MD, Ph.D., says, “We are disappointed with 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, demonstrated in the FINCH Phase 3 clinical program. “
Galapagos revised its cash consumption guidance in 2020 to € 520M from € 490M as a result.
