EUROPEAN COMMISSION GRANTS MARKETING AUTHORIZATION FOR JYSELECA (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE ACTIVE RHEUMATHOID ARTHRITIS - Seite 2

Across the FINCH and DARWIN trials,¹⁴ the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness.¹ Rates of herpes zoster and pneumonia were uncommon.¹ The frequency of serious infections in the Jyseleca 200 mg group was 1.0 percent compared with 0.6 percent in the placebo group.¹

In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with Jyseleca were comparable to placebo.⁶ The rates of serious infections remained stable with long-term exposure.¹

“Jyseleca, the first medicine from Galapagos to obtain regulatory approval is the result of a strong commitment to addressing unmet medical need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “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.”

“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,” said Onno van de Stolpe, Chief Executive Officer, Galapagos. “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.”

Under the collaboration agreement, Galapagos will now receive a milestone payment of $75 million in recognition of the approval of Jyseleca by the European Commission.

About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety of Jyseleca 200 mg and 100 mg once-daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 was a 52‑week, randomized, placebo- and adalimumab-controlled trial in combination with MTX, enrolling 1,759 adult patients with moderate to severe active RA who had inadequate response to MTX. The primary endpoint in FINCH 1 was ACR20 at Week 12. The trial included radiographic assessment at Weeks 12, 24 and 52. FINCH 2 was a global, 24-week, randomized, double-blind, placebo-controlled, Phase 3 study evaluating Jyseleca on a background of csDMARDs among 449 adult patients with moderate to severe active RA who had not adequately responded to biologic DMARDs (bDMARDs). The primary endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52‑week, randomized trial in 1,252 MTX-naïve patients to evaluate Jyseleca 200 mg alone and Jyseleca 200 mg or 100 mg combined with MTX versus MTX alone in MTX-naïve patients. The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial included radiographic assessment at Weeks 24 and 52.