EU Commission Grants Marketing Authorization for Gilead’s Rheumatoid Arthritis Treatment
By Pavel Ryzhov, Ph.D.
Rheumatoid arthritis (RA) is a chronic autoimmune disease affecting 1.3 million Americans, 3 million people in Europe, and many others worldwide. It is characterized by joint pain that leads to progressive and irreversible joint damage and impairment, significantly affecting the quality of life. While the precise cause of RA is unknown, several contributing factors are identified. Among others, they include older age, sex (2-3x more prevalent in women), genetics (human leukocyte antigen class II genotypes), smoking, and obesity .
Existing therapies have been shown to treat RA, manage symptoms, slow disease progression, and eliminate the deformity of the joints. They include disease-modifying antirheumatic drugs (DMARDs) like methotrexate (MTX), biologics, non-steroid anti-inflammatory drugs (NSAIDs), steroids, and self-management therapies that aim to maintain the existing quality of life. While the abundance of available treatment options is growing, there are still patients who may not respond to them, and new medicines are being developed.
One of them, Jyseleca®, an oral small molecule drug, has just been approved for commercialization in the EU . According to the press-release from Gilead Sciences, Inc. and Galapagos NV, Jyseleca received its marketing authorization for the treatment of moderate to severe active RA in adults who previously responded poorly or are intolerant to one or more DMARDs. The drug, filgotinib, is an inhibitor of Janus Kinase 1 (JAK1), a tyrosine kinase responsible for signaling with major cytokine receptors on the cell surface.
The decision to approve Jyseleca was based on the data from over 3,500 patients enrolled in Phase 2 (DARWIN [3,4,5]) and Phase 3 (FINCH [6,7,8,9]) clinical trials. In the latter, the medicine achieved ACR20/50/70 (American College of Rheumatology) criteria, used to evaluate the effectiveness of RA medications. The improvements across individual ACR components (like acute phase reactant, patient and physician assessment, pain scale, disability/functional questionnaire) were shown compared to placebo and MTX.
Furthermore, as assessed with a modified Total Sharp Score at Week 24, treatment with Jyseleca and MTX achieved statistically significant inhibition of structural joint damage progression in patients with inadequate response to MTX alone. The most common adverse side effects of administering Jyseleca were nausea, dizziness, and infections of upper respiratory and urinary tracts. Safety analysis of major adverse cardiac events and venous thromboembolism revealed the drug to be comparable to placebo.
The successful marketing authorization was celebrated by Daniel O’Day, Chairman, and CEO of Gilead Sciences. He said the approval is the “result of a strong commitment to addressing unmet clinical need” and noted that through “collaboration with Galapagos we can help to deliver many new solutions for patients in the future.” His comments were echoed by Onno van de Stolpe, CEO of Galapagos, who remarked “years of research and commitment to make meaningful changes in the lives of [RA] patients” and celebrated “the efficacy and safety profile of Jyseleca” that was recognized by the European Commission. Notably, As a result of this achievement, Galapagos is scheduled to receive a milestone payment of $75 million from Gilead.