FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the New Drug Application (NDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis (RA) has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW).
The NDA for filgotinib is supported by data from the Phase 3 FINCH clinical trial program in which once-daily treatment with filgotinib demonstrated the potential to improve clinical signs and symptoms, to achieve low disease activity and remission, and to inhibit structural damage for patients living with RA. Safety data across the FINCH clinical trial program was consistent with previously reported results.
“Despite multiple medications currently available to treat rheumatoid arthritis, there are still far too many people who do not experience adequate relief from their symptoms,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences. “The FINCH clinical trial program demonstrated that filgotinib may offer a wide range of people living with RA, including those in the early treatment and those who have tried standard therapies without success, an important new treatment option.”
“This new drug application is an important milestone as we continue to expand Gilead’s presence in Japan to now also include inflammation,” said Luc Hermans, MD, President and Representative Director, Gilead Sciences, K.K. “We are committed to bringing innovative products to patients and healthcare providers in Japan, expanding beyond antivirals into new areas where our medicines can make a meaningful difference to patients.”
There are estimated to be up to one million people living with RA in Japan.
Filgotinib is an investigational agent and is not approved anywhere globally. Its efficacy and safety have not been established by any regulatory authorities.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 is a 52-week, randomized, placebo- and adalimumab-controlled trial in combination with methotrexate (MTX) that enrolled 1,759 adult patients with moderately to severely active RA who have had an inadequate response to MTX. The primary endpoint was ACR20 at week 12. The trial included radiographic assessment at weeks 24 and 52. FINCH 2 was a 24-week, randomized, placebo-controlled trial in 449 patients who were receiving conventional disease-modifying anti-rheumatic drugs (cDMARD) and had a prior inadequate response to one or more biological therapies. The primary endpoint was ACR20 at week 12. FINCH 3 is a 52-week, randomized trial in 1,252 MTX-naïve patients to study filgotinib in combination with MTX, as well as monotherapy. The primary endpoint was ACR20 at week 24. Radiographic progression was also assessed.
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.
For more information on Gilead Sciences K.K., please visit the company’s website at https://www.gilead.co.jp/.
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 risk that the MHLW and other regulatory agencies may not approve filgotinib for the treatment of RA, and any marketing approvals, if granted, may have significant limitations on its use. As a result, filgotinib may never be successfully commercialized. Further, there is the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib. 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 June 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.