Jyseleca secures European approval in rheumatoid arthritis
pharmafile | September 28, 2020 | News story | Research and Development, Sales and Marketing | Europe, Jyseleca, arthritis, pharma
The European Commission has awarded approval to Gilead and Galpagos for their oral JAK inhibitor Jyseleca (filgotinib) as a treatment for moderate to severe active rheumatoid arthritis, either as a monotherapy or in combination with methotrexate (MTX), in patients who have failed to respond or proved intolerant to at least one disease‑modifying anti‑rheumatic drug (DMARD).
The decision was made off the back of Phase 2 and 3 data drawn from 3,500 patients in which Jyseleca was shown to successfully halt the progression of structural joint damage, with durable efficacy over 52 weeks of treatment.
Around 400,000 in the UK and 45,000 in Ireland live with RA, with moderate to severe forms of the condition accounting for around 70% of all cases, but currently less than 20% of RA patients manage to achieve disease remission.
“Unbelievably, it is still common for people to mistake rheumatoid arthritis as just wear and tear or ‘part of getting old’ and this leads to deep misunderstanding and an underestimation of the reality of this debilitating painful condition,” explained Clare Jacklin, CEO of the National Rheumatoid Arthritis Society (NRAS). “New options that can help alleviate symptoms are sorely needed and we therefore welcome today’s news as another important step forward for lessening the burden of RA on the individual, their families, the health service and the economy.”
This decision in Europe follows the drug’s authorisation in Japan last week.
Matt Fellows
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