FDA rejects filgotinib for moderate to severe active RA due to testicular toxicity
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Gilead announced the FDA has issued a complete response letter regarding the new drug application for filgotinib as a treatment for moderately to severely active rheumatoid arthritis.
The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons. In this case, the FDA expressed concerns of testicular toxicity previously associated with high doses of filgotinib.
Source: FDA.gov
“We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, said in a press release. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH phase 3 clinical program.”
As a potential fourth JAK inhibitor for moderate-to-severe RA and a serious contender in this arena, filgotinib has been plagued by lingering concerns regarding its testicular toxicity. In an attempt to address these concerns, Gilead is currently conducting the MANTA study, a safety trial examining male reproductive safety of filgotinib in men with moderate to severe IBD, and the MANTA-RAy study, examining semen parameters of the drug in men with active RA, psoriatic arthritis, ankylosing spondylitis and nonradiographic axial spondyloarthritis.
“In routine animal studies of filgotinib, changes in semen parameters were observed in some animals receiving filgotinib at levels well above the highest intended clinical dose,” Sonia Choi, a Gilead spokesperson, told Healio Rheumatology. “The MANTA study seeks to understand whether this finding [of changes in semen parameters] has any clinical relevance in men.”
Although filgotinib recently obtained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the treatment of moderate to severe RA, the FDA has requested data from both MANTA and MANTA-RAy studies before completing its review of the NDA. Gilead noted that the agency “has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.”
“This CRL issued by the FDA is very disappointing given the robust and comprehensive data package provided,” Walid Abi-Saab, MD, chief medical officer at Galapagos, said in a press release. “Despite today’s news, we continue to believe filgotinib has the potential to provide an effective, new treatment option for patients with rheumatoid arthritis, where there remains a significant unmet need.”
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