Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the US Food and Drug Administration (FDA) has issued a full response letter (CRL) to the New Drug Application (NDA) for filgotinib, a research treatment for moderate to severe active rheumatoid arthritis (RA).
The FDA requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The MANTA and MANTA-RAy studies are designed to assess whether filgotinib affects sperm parameters. The FDA has also expressed concerns about the overall benefit / risk profile of the filgotinib 200 mg dose.
“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, as demonstrated in the FINCH Phase 3 clinical program. , “said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
The MANTA and MANTA-RAy studies are fully recruited, with topline results expected in the first half of 2021. Filgotinib is currently being investigated by regulatory authorities around the world. Filgotinib recently received a positive opinion from the Committee of the European Medicines Agency for Human Use, and recommends marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe RA who have not responded well enough or are irresponsible for one or more disease modification of anti-rheumatic drugs.
On the collaboration of Filgotinib
1“data-reactid =” 27 “>On the collaboration of Filgotinib1Gilead and Galapagos NV are collaborators in the worldwide development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications. The companies have conducted several clinical study programs for filgotinib in inflammatory diseases, including the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, such as Phase 2 studies in uveitis and in small bowel and fistulizing disease of Crohn’s. More information on clinical trials with filgotinib is available at: www.clinicaltrials.gov.
About Gilead Sciences“data-reactid =” 29 “>About Gilead Sciences
Gilead Sciences, Inc. is a bio-pharmaceutical company-based research that discovers, develops and commercializes innovative medicines in areas of medical need. The company strives to care for and simplify care for people with life-threatening illnesses around the world.
Gilead has operations in more than 35 countries worldwide, headquartered in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Report for Gilead ahead“data-reactid =” 32 “>Report for Gilead ahead
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which are subject to risks, uncertainties and other factors, including the possibility of adverse results from ongoing and additional clinical studies that ‘ t contains filgotinib, including the MANTA and MANTA-RAy studies, and the possibility that the parties may not be able to complete one or more of these studies within the currently expected timeline or at least. There is also the risk that the FDA and the European Commission may not approve filgotinib for the treatment of moderate to severe rheumatoid arthritis within the currently expected timelines or at all, and any marketing approvals, if allowed, may have significant limitations. on its use. Furthermore, it is possible that the parties may make a strategic decision to stop the development of filgotinib, and as a result, filgotinib may never be successfully commercialized. All statements other than statements of historical fact are statements that could be considered as forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those mentioned in the forward-looking statements. The reader is cautious not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All statements made are based on information currently available to Gilead, and Gilead is under no obligation to update such statements.
