CA-GILEAD-SCIENCES
19.12.2019 22:32:04 CET | Business Wire | Press release
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 Collaborationi
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 )
View source version on businesswire.com: https://www.businesswire.com/news/home/20191219005768/en/
Link:
About Business Wire
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
Pacífico Mexinol Celebrates the Symbolic Groundbreaking in Topolobampo, Positioning Mexico in the New Low-Carbon Chemical Industry24.4.2026 02:29:00 CEST | Press release
The initiative brings together governments, diplomats, and global investors around a Net Zero industrial model. The project establishes Topolobampo, Sinaloa as a key hub for industrial development in North America. The Pacifico Mexinol project (“Mexinol”) celebrated the beginning of its pre-construction phase by symbolically laying a first stone, marking the start of one of the most significant global industrial investments in blue and ultra-low carbon methanol. The event brought together diplomats, authorities, and national and international business leaders, reflecting the project’s strategic importance for Mexico and its integration into the emerging low-carbon economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423775301/en/ Adolfo Murietta, Project Shareholder; Rommel Gallo, CEO Transition Industries; Ron Johnson, United States Ambassador to Mexico; Drew Hoster, Counsel General of the United States in Hermosillo,
The New World ID: Proof of Human for the AI Era Scales Across the Digital Platforms People and Businesses Use Every Day24.4.2026 02:20:00 CEST | Press release
Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers Last week, World announced the next generation of World ID, its proof of human protocol, designed to increase trust on the internet. The announcement was made during “Lift Off,” a live event in San Francisco. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260417530721/en/ Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers As AI makes it easier than ever to generate convincing content, identities, and interactions, trust online has decreased. World ID addresses this challenge by enabling individuals to privately prove they are a real, unique human, without revealing their identity across apps, platforms, and services. “If anything online can be faked, you no longer know who or what to trust,” said Tiago Sada, Chief Product Officer at Tools for Humanity, a co
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
Venture Global Announces Closing of $750,000,000 Senior Secured Notes by Venture Global Calcasieu Pass, LLC23.4.2026 19:47:00 CEST | Press release
Venture Global, Inc. (“Venture Global”, NYSE: VG) announced today that its subsidiary, Venture Global Calcasieu Pass, LLC (“VGCP”) has closed an offering of $750,000,000 aggregate principal amount of 6.000% senior secured notes due 2036 (the “Notes”). The Notes will mature on May 1, 2036. VGCP used the net proceeds from the offering, together with cash on hand and proceeds received from certain hedge terminations, for the prepayment, in full, of VGCP’s outstanding term loans, and to pay fees and expenses in connection with the offering. The Notes are guaranteed by TransCameron Pipeline, LLC (VGCP’s affiliate). The Notes are secured on a pari passu basis by a first-priority security interest in the assets that secure VGCP’s existing senior secured first lien credit facilities and VGCP’s existing senior secured notes. The Notes were not registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdictions, and the Notes
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
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