Wednesday, August 19, 2020 9:45:13 AM
Mechelen, Belgium; 19 August 2020, 01.25 CET; regulated information – Galapagos (Euronext & Nasdaq: GLPG) announces today that Gilead Sciences, Inc. (Nasdaq: GILD) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA). The FDA issues CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. Gilead is the market authorization holder for filgotinib in the United States and is responsible for potential commercialization in the U.S.
The FDA has 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 has an impact on sperm parameters. The FDA also has expressed concerns regarding 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, which has been demonstrated in the FINCH Phase 3 clinical program,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
“This CRL issued by the FDA is very disappointing given the robust and comprehensive data package provided. 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,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
The MANTA and MANTA-RAy studies are fully recruited, with topline results anticipated in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world. Filgotinib recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending marketing authorization for 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 disease-modifying anti-rheumatic drugs.
Recent ABBV News
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/08/2024 09:00:46 PM
- QULIPTA(MC) (atogépant) est maintenant approuvé par Santé Canada pour la prévention de la migraine chronique chez les adultes • PR Newswire (Canada) • 05/08/2024 12:00:00 PM
- QULIPTA™ (atogepant) Now Approved by Health Canada for the Preventive Treatment of Chronic Migraine in Adults • PR Newswire (Canada) • 05/08/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/08/2024 12:16:28 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/07/2024 10:31:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/07/2024 10:30:34 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/07/2024 10:30:28 PM
- AbbVie to Present at the Bank of America Securities Healthcare Conference • PR Newswire (US) • 05/06/2024 12:00:00 PM
- U.S. Futures Climb in Pre-Market Trading Amid Tech Gains and Upcoming Inflation Data • IH Market News • 04/26/2024 11:47:25 AM
- AbbVie Reports First-Quarter 2024 Financial Results • PR Newswire (US) • 04/26/2024 11:35:00 AM
- New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study • PR Newswire (US) • 04/25/2024 12:00:00 PM
- Allergan Aesthetics Invites Consumers to Be the Face of BOTOX® Cosmetic (onabotulinumtoxinA) and Their Other Biggest Brands • PR Newswire (US) • 04/23/2024 12:00:00 PM
- Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis • PR Newswire (US) • 04/18/2024 12:31:00 PM
- AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine • PR Newswire (US) • 04/12/2024 11:30:00 AM
- SkinMedica® Empowers Clear Skin Confidence with a New, Modern Approach to Acne • PR Newswire (US) • 04/09/2024 12:00:00 PM
- AbbVie to Host First-Quarter 2024 Earnings Conference Call • PR Newswire (US) • 04/04/2024 12:00:00 PM
- Allergan Aesthetics Announces the Return of CoolMonth with CoolSculpting® • PR Newswire (US) • 04/03/2024 12:30:00 PM
- NEXGEL Reports Full Year 2023 Revenue of $4.1 Million, an Increase of 99.7% Year-Over-Year • GlobeNewswire Inc. • 04/01/2024 11:50:00 AM
- Super Micro Computer and Seagate Shares Surge on Analyst Optimism in Pre-Market Trading, and Latest News • IH Market News • 03/26/2024 11:20:49 AM
- Allergan Aesthetics Launches "Moving the Needle on Ethics" to Elevate the Conversation Around Ethics in Aesthetics • PR Newswire (US) • 03/25/2024 03:00:00 PM
- AbbVie to Acquire Landos Biopharma, Further Strengthening its Portfolio in Inflammatory and Autoimmune Diseases • PR Newswire (US) • 03/25/2024 12:31:00 PM
- AbbVie to Acquire Landos Biopharma, Further Strengthening its Portfolio in Inflammatory and Autoimmune Diseases • GlobeNewswire Inc. • 03/25/2024 12:30:00 PM
- U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients • PR Newswire (US) • 03/22/2024 07:02:00 PM
- ALLERGAN AESTHETICS CONTINUES TO CHAMPION INDIVIDUALITY, DRIVE INNOVATION AND LEAD WITH INTEGRITY AS IT HOSTS EXPERT LED SYMPOSIA AT AMWC 2024 • PR Newswire (US) • 03/21/2024 12:00:00 PM
- AbbVie to Present at the Barclays 26th Annual Global Healthcare Conference • PR Newswire (US) • 03/07/2024 01:00:00 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM