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
Follow-on Order Brings Orders from INNIO Data Center Customer to 1.72 GW, Further Strengthening INNIO’s Data Center Backlog and Revenue Visibility22.10.2026 14:30:00 CEST | Press release
Customer also signs long-term full maintenance agreement for first 500 MW, expanding INNIO’s recurring services base. INNIO N.V. (Nasdaq: INIO) today announced a 620 megawatt (MW) follow-on order from a leading developer and operator of mega-scale data center campuses in the U.S. Together with the customer’s 1.1 gigawatt (GW) order announced in July 2026, the new order brings cumulative orders from the customer to approximately 1.72 GW, further strengthening INNIO’s order backlog and visibility into future revenues. “This follow-on order, coming just months after the customer’s initial 1.1 GW order, underscores the strength of customer demand and continued confidence in INNIO. Our containerized Jenbacher solutions deliver what data centers need most: fast deployment, high power density, fuel efficiency, and the performance to support demanding AI workloads,” said Dr. Olaf Berlien, President and CEO of INNIO. “Repeat orders of this scale, combined with long-term service agreements, stre
European Public Transport Budgets Require 36% Annual Spending Increase by 2035, Arthur D. Little and Polis Research Finds22.10.2026 14:30:00 CEST | Press release
Europe’s public transport sector currently accounts for €130 billion in annual expenditure, yet faces a growing funding gap as demand rises and environmental and resilience requirements intensify. New research from Arthur D. Little (ADL)’s Future of Mobility Lab and POLIS, a network of European cities and regions collaborating to develop innovative and sustainable urban transport solutions, outlines the scale of this financial shortfall and provides radical recommendations for overcoming it. Based on research with senior transport and policymakers, in-depth literature reviews, and real-world data from Paris, London, Amsterdam, Berlin and New York, the report estimates that additional spending will require a 36% increase in overall annual expenditure from now to 2035 onwards. This is made up of a 13% rise in operating expenditure (OPEX) and 56% in capital expenditure (CAPEX), driven by: Hidden debt caused by historic underinvestment in existing infrastructure (6% of additional funding n
Hitachi Report Examines Readiness for Physical AI in Industrial Companies22.10.2026 14:00:00 CEST | Press release
AI adoption progress, trends, and emerging priorities suggest opportunities and challenges for physical AI acceleration Hitachi, Ltd. (TSE:6501, "Hitachi") announced the release of its physical AI survey-based research report, Beyond the Pilot: Industry’s Physical AI Progression. The company surveyed over 200 global decision-makers from organizations operating in mission-critical industrial sectors including energy, manufacturing, transportation and logistics. The report explores how businesses today adopt AI in industrial use-cases, where they see the greatest value, and what it will take to scale toward physical AI deployments. Readers will gain practical insights on how to accelerate AI adoption while improving competitiveness, productivity, and long-term business performance. After successfully transforming knowledge work, AI is now entering the physical systems that form society’s backbone: energy, industrial, and mobility infrastructure, to name a few. Given these systems’ reliab
Datavault AI Signs Non-Binding Letter of Intent to Acquire a 19.9% Equity Stake in DataMEDS AI in Consideration of an Expanded Technology License22.10.2026 14:00:00 CEST | Press release
Expanded healthcare platform would bring together patient-controlled data tokenization, biometric medication verification, and automated delivery technologies Datavault AI Inc. (“Datavault AI” or the “Company”) (Nasdaq: DVLT), an Artificial Intelligence Platform (“AIP”) company providing data monetization, credentialing, and real-world asset (“RWA”) tokenization, today announced that it has entered into a non-binding letter of intent (“LOI”) to acquire a 19.9% equity interest in DataMEDS AI, Inc. (NASDAQ: MEDS) (“DataMEDS”) in consideration of an expansion of its existing technology license with DataMEDS. The proposed transaction is subject to completion of due diligence and negotiation of definitive agreements and will be subject to customary closing conditions for a transaction of this nature. The proposed transaction is structured to provide Datavault AI with the opportunity to obtain an equity interest in DataMEDS while preserving ownership of its underlying intellectual property.
Megaport Expands AWS Connectivity With AWS Interconnect to Simplify How Customers Connect Their Infrastructure22.10.2026 14:00:00 CEST | Press release
As one of a select group of providers, Megaport adds AWS Interconnect to its complete suite of AWS connectivity options. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced support for AWS Interconnect, a new managed connection model from Amazon Web Services (AWS) designed to simplify how businesses connect their infrastructure to AWS. AWS Interconnect from Megaport gives enterprises and AI infrastructure providers an automated connectivity option as their requirements grow beyond traditional AWS Hosted Connections. MACsec encryption and four redundant links across two sites will be included as part of the service at general availability, with customers able to select connection speeds from 1 Gbps to 100 Gbps. Customers can start an order for AWS Interconnect - last mile from either the Megaport Portal or AWS Management Console and complete it from the other. AWS and Megaport then automate the underlying network configuration, i
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