Publication date: 19/12/2019
Galapagos NV (Euronext & NASDAQ: GLPG) today announced that its collaboration partner, Gilead Sciences, Inc. (NASDAQ: GILD) 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 NDA 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.
As part of the collaboration terms, upon NDA submission, Galapagos receives a $20 million milestone payment from Gilead.
This NDA is the third regulatory agency submission for filgotinib in the past 5 months following submissions to the European Medicines Agency and Japanese Ministry of Health, Labor and Welfare earlier this year.
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.”
“Following submission for approval of filgotinib in RA with the European and Japanese authorities, today’s announcement marks another key step in Galapagos’ history: a first ever NDA submission for one of our programs,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “We are excited about the progress made, and look forward to hopefully bringing filgotinib to patients suffering from RA across these territories.”
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 are collaborative partners in the global development and commercialization of filgotinib in RA, and other potential inflammatory indications. In the U.S., Gilead is solely responsible for the commercialization of filgotinib, pending approval of filgotinib by the FDA, and Galapagos is eligible for further milestones as well as royalties of 20-30% on filgotinib sales in this territory. If approved, Gilead and Galapagos will co-commercialize filgotinib in a number of European territories.
Galapagos (Euronext & NASDAQ: GLPG) discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Galapagos’ pipeline comprises Phase 3 through to discovery programs in inflammation, fibrosis, osteoarthritis and other indications. The Company’s ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
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.