The EC has granted marketing authorisation for Jyseleca based on data from the Phase 3 FINCH and Phase 2 DARWIN clinical trial programmes
EC approves Jyseleca to treat rheumatoid arthritis. (Credit: Sébastien Bertrand.)
Gilead Sciences and Galapagos have secured the European Commission (EC) approval to market Jyseleca (filgotinib) 200mg and 100mg tablets, to treat a type of rheumatoid arthritis (RA).
EC indicated Jyseleca as a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severely active RA who have inadequately responded, or intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
The drug can be used as monotherapy or in combination with methotrexate (MTX).
Gilead Sciences chairman and chief executive officer Daniel O’Day said: “Jyseleca, the first medicine from Galapagos to obtain regulatory approval is the result of a strong commitment to addressing the 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.”
Gilead and Galapagos partnered to develop and commercialise Jyseleca
Gilead has partnered European pharmaceutical research company Galapagos, for the global development and commercialisation of Jyseleca in RA and other inflammatory indications.
Galapagos is engaged in the discovery and development of small molecule medicines with novel modes of action. The company’s pipeline includes Phase 3 programmes in inflammation, fibrosis, osteoarthritis and other indications
Along with the EC marketing authorisation, the partnership has also secured the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for Jyseleca for the same indication.
Pursuant to the terms of their collaboration agreement, Galapagos is now entitled to receive $75m, in milestone payment based on the EC approval for Jyseleca.
Galapagos chief executive officer Onno van de Stolpe 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.”
The European regulatory agency has granted the marketing authorisation based on data from the Phase 3 FINCH and Phase 2 DARWIN programmes, in which more than 3,500 patients are treated with Jyseleca.
In FINCH trial, treatment using Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX, said the company.
Most patients treated using Jyseleca 200mg plus MTX or other conventional DMARDs showed reduced disease activity compared to placebo or MTX.
In patients who are not responsive to MTX, treatment with Jyseleca plus MTX showed significant inhibition of progression of structural joint damage compared to placebo plus MTX, as assessed using the modified Total Sharp Score (mTSS).
In Phase 2 DARWIN extension trial, patients treated with Jyseleca 200mg as monotherapy or with MTX durable showed ACR20/50/70 responses, maintained for up to three years.
The most common adverse reactions across the FINCH and DARWIN trials include nausea, upper respiratory tract infection, urinary tract infection and dizziness.
University of Oxford musculoskeletal sciences professor Peter Taylor said: “Despite the availability of existing therapies, new treatment options are still needed to help optimally manage the impact of RA on patients’ daily lives.
“Jyseleca has demonstrated robust symptom control and prevention of disease progression with a consistent safety profile across the clinical development program. This marketing authorization provides a welcome new option for people in Europe living with this debilitating and complex disease.”