Jyseleca EC approval : Gilead Sciences and Galapagos have secured marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets) from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults.

The approval of the once-daily, oral, JAK1 inhibitor is rheumatoid arthritis patients who showed inadequate response to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs).

As per the approval, Jyseleca can be used either as a monotherapy or in combination with methotrexate (MTX).

In July 2019, Gilead Sciences and the Belgian pharma company Galapagos entered into a $4.96 billion collaboration deal, under which the former gains access to the latter’s portfolio of compounds. These include six molecules, over 20 preclinical programs, and a drug discovery platform.

Filgotinib is part of the same deal with the companies partnering in its global development and commercialization in rheumatoid arthritis and other inflammatory indications.

Under the collaboration deal, Galapagos will now get a milestone payment of $75 million for Jyseleca EC approval.

Daniel O’Day – Chairman and CEO of Gilead Sciences, commenting on Jyseleca EC approval, said: “Jyseleca, the first medicine from Galapagos to obtain regulatory approval is the result of a strong commitment to addressing unmet medical need.

“We look forward to making continued progress through our collaboration with Galapagos so we can help to deliver many new solutions for patients in the future.”

The Jyseleca EC approval has been driven by the findings of the phase 3 FINCH and phase 2 DARWIN clinical programs.

In the FINCH studies, Jyseleca achieved ACR20/50/70 criteria consistently by delivering improvements in all individual ACR components in comparison to placebo or methotrexate.

Commenting on Jyseleca EC approval, Onno van de Stolpe – CEO of Galapagos, said: “Today’s announcement is a proud day for everyone at Galapagos, recognizing years of research and commitment to make a meaningful change in the lives of patients struggling with the symptoms of RA.

“This news further affirms the efficacy and safety profile of Jyseleca, and we look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.”

Jyseleca also received approval in Japan for the treatment of rheumatoid arthritis in patients with inadequate response to conventional therapies. The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) also covers Jyseleca’s approval for the prevention of structural joint damage.

Gilead Japan, a subsidiary of Gilead Sciences, will hold the marketing authorization of Jyseleca in the country and will be responsible for its product supply, while Eisai will be responsible for product distribution.

  Daniel O’Day, Eisai, European Commission, European Union, filgotinib, Galapagos, Gilead Sciences, JAK1 inhibitor, Japan, Jyseleca, Onno van de Stolpe, Rheumatoid arthritis