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Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Request (NDA) for filgotinib , an investigational treatment for moderately to severely active rheumatoid arthritis (RA) patients.
The FDA requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The MANTA and MANTA-RAy studies aim to assess whether filgotinib has an impact on sperm parameters. The FDA also expressed concerns about the overall benefit / risk profile of the 200 mg dose of filgotinib.
“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 ”. said Merdad Parsey, MD, PhD, medical director of Gilead Sciences.
The MANTA and MANTA-RAy studies are fully recruited, with the first results expected in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world. Filgotinib recently received a favorable opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending the marketing authorization of filgotinib in the EU for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant of one or more diseases. modification of anti-rheumatic drugs.
About the Filgotinib collaboration1
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in rheumatoid arthritis and other inflammatory indications. The companies have 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 Phase 3 DIVERSITY trial in Crohn’s disease, the PENGUIN phase 3 trials in psoriatic arthritis, as well as phase 2 studies in uveitis and in small and fistulizing Crohn’s disease. More information on clinical trials with filgotinib is available at: www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and markets innovative drugs in areas where medical needs are unmet. The company works to transform and simplify care for people with life-threatening illnesses around the world.
Gilead operates in more than 35 countries around the world, with its headquarters in Foster City, California. For more information about Gilead Sciences, please visit the company’s website at www.gilead.com.
Gilead’s forward-looking statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of adverse results from ongoing and additional clinical studies involving filgotinib , including the MANTA and the MANTA-RAy studies and the possibility that the parties will not be able to complete one or more of these studies within the current time frame or not at all. There is also a risk that the FDA and the European Commission will not approve filgotinib for the treatment of moderate to severe rheumatoid arthritis on schedule or not at all, and any marketing authorization, if it is. granted, may have significant limitations on its use. In addition, it is possible that the parties may make a strategic decision to discontinue the development of filgotinib and, therefore, filgotinib may never be successfully marketed. All statements other than statements of historical fact are statements which could be considered as forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those mentioned in forward-looking statements. The reader is cautioned 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 United States Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update these forward-looking statements.
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