Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
The filing is supported by 52-week data from the global Phase 3 FINCH clinical program, which evaluated the efficacy and safety of filgotinib in 3,452 patients with moderate to severely active RA. In the FINCH studies, filgotinib met its primary endpoints and demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve. Safety results were consistent across the trials and further reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients.
Despite the availability of current therapies, people living with RA may face persistent disease symptoms and inadequate responses to currently available therapies. One in five patients do not achieve complete disease remission during their lifetimes and remain in need of treatment options.
“The new drug application submission for filgotinib represents an important step forward in bringing a potential new treatment option to people living with RA,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “In clinical trials, filgotinib has demonstrated an efficacy and tolerability profile that may offer meaningful improvements in RA treatment response for patients with this chronic, debilitating disease.”
This filing is the third regulatory agency submission for filgotinib in the past five months following submissions to the European Medicines Agency and Japanese Ministry of Health, Labor and Welfare earlier this year.
Filgotinib is an investigational agent and is not approved by any regulatory authority. Its efficacy and safety have not been established.
About the Filgotinib Collaboration i
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in RA, and other potential inflammatory indications. In the United States, Gilead is solely responsible for the commercialization of filgotinib, pending approval of filgotinib by the FDA.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Gilead Forward-Looking Statement
This press release includes 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 unfavorable results from ongoing and additional clinical trials involving filgotinib and the possibility that we may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that the parties may make a strategic decision to discontinue 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 deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
__________________
i Gilead & Galapagos Filgotinib Clinical Program Trial Details: SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191219005768/en/
Contact information
Greg Mann, Investors
(424) 322-1795
Arran Attridge, Media
(650) 425-8975
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EIG Acquires a 49.87% Stake in Transportadora de Gas del Perú (TgP)19.12.2025 19:42:00 EET | Press release
EIG, through its managed investment vehicles, acquired a 49.87% equity stake in Transportadora de Gas del Perú S.A. (“TgP”) from Canada Pension Plan Investment Board today. TgP operates Peru’s principal natural gas and natural gas liquids pipelines under a long-term concession, supplying approximately 40% of the country’s power generation. “We are delighted to complete this transaction and embark on the next chapter of our partnership with TgP,” said Matt Hartman, EIG’s Global Head of Infrastructure. “Our priority is to support TgP’s operational excellence and long-term stability, delivering value for customers and stakeholders throughout Peru.” About EIG EIG is a leading institutional investor in the global energy and infrastructure sectors with $24.3 billion assets under management as of September 30, 2025. EIG specializes in private investments in energy and energy-related infrastructure on a global basis. During its 43-year history, EIG has committed over $51.7 billion to the energ
CyberArk Named a Leader in IDC MarketScape: Worldwide Integrated Solutions for Identity Security 202519.12.2025 18:00:00 EET | Press release
CyberArk (NASDAQ: CYBR), the global leader in identity security, today announced that it has been recognized as a Leader in the IDC MarketScape: Worldwide Integrated Solutions for Identity Security 2025 Vendor Assessment. CyberArk extends dynamic privilege controls across all identity types with its unified platform, enabling organizations to improve efficiencies and streamline security operations. This IDC MarketScape report notes, “More change has occurred in the identity security marketplace in the past two years than in almost a decade. Vendors are entering a new phase defined by the emergence of intelligence technologies, none of which are specifically defined by any industry standards. Though different by design, the new adjacent IAM offerings are largely focused on improved vulnerability and threat management visibility and automated and predictive attack detection capabilities.” It also notes, “By addressing these evolving identity types within a unified framework, CyberArk enh
New York Liberty and Ant International’s Alipay+ Announce Multiyear Partnership Focused on Empowerment, Sustainability and Youth Development19.12.2025 15:30:00 EET | Press release
The New York Liberty and Ant International’s Alipay+, a leading cross-border fintech services platform based in Singapore, today announced a multiyear partnership, making Alipay+ an Official Sponsor and Innovation Partner for Sustainability of the New York Liberty. Through this partnership, Alipay+ and the Liberty will jointly support community programs designed to advance community empowerment, environmental sustainability and youth development across New York City. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219678825/en/ Peng Yang, CEO, Ant International and Clara Wu Tsai, Vice Chair, Brooklyn Sports and Entertainment; Governor, New York Liberty “Our partnership with Alipay+ goes beyond the game,” said Keia Clarke, Chief Executive Officer, New York Liberty. “Together, we are investing in the future of New York—its people, its environment, and its youth. Ant International’s commitment to community empowerment, sustai
Parse Biosciences and Codebreaker Labs Partner to Apply Whole Transcriptome Single Cell Profiling and Causal Genomics at Scale19.12.2025 15:00:00 EET | Press release
Parse Biosciences, the leading provider of scalable and accessible single cell sequencing solutions, today announced a collaboration with Codebreaker Labs to develop and validate a breakthrough platform capable of testing thousands of genetic variants in parallel and measuring their effects at single cell resolution. By combining Codebreaker’s synthetic biology platform and variant engineering capabilities with the scale and accessibility of Parse’s Evercode™ technology, the collaboration aims to generate the causal data increasingly sought by AI developers, drug discovery teams, and clinical researchers. Today’s genomic studies rely heavily on observational data, or variants that appear in large populations. But rare and private variants, often only seen in one individual or family, are nearly impossible to study this way because too few carriers of the variant exist to draw statistically meaningful conclusions. As a result, even the most advanced models trained on observational datas
Cyviz Awarded Two Classified NATO Defense Contracts19.12.2025 09:00:00 EET | Press release
Norwegian technology and platform company Cyviz AS has been awarded two classified defense contracts by major European NATO-partner nations to deliver a fully mobile, containerised Command & Control (C2) capability, strengthening Europe’s operational readiness in high-threat and expeditionary environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218625485/en/ Image from a previous military exercise where Cyviz demonstrated a mobile command center solution. The contracts cover the design, integration, and delivery of secure, deployable operations centres engineered to NATO security standards, enabling military and security forces to establish full theatre-class command capability wherever operations require. Due to the sensitive nature of the missions, contract value and customer identities remain undisclosed. From Demonstrated Readiness to Operational Deployment The awards follow growing interest among European def
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom