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NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis

Galapagos NV (Euronext & Nasdaq: GLPG) welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA® (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier – potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 RA is a degenerative auto-immune disease that can cause life-threatening complications.4 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England.5,6

 “We are delighted with the NICE recommendation for Jyseleca today. For patients with moderate to severe RA in England this decision represents a significant new opportunity and especially for those with moderate symptoms who can now receive an advanced treatment earlier,” said Onno van de Stolpe, Galapagos CEO.

Filgotinib is a once daily oral pill that can be given on its own (as a monotherapy) or used alongside another common RA medicine, called methotrexate.7 Eligible patients with moderate or severe RA will have responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs).1 Eligible patients with severe disease will also have wider access to filgotinib in line with criteria defined by NICE. Filgotinib is an advanced therapy which, in RA, is a term used to describe biologic DMARDs and targeted synthetic DMARDs.1

More than 400,000 people in the UK live with RA (around 380,000 in England), and it is recognised as a condition that can cause debilitating physical pain, affect mental health and require chronic care.2 Studies have shown that RA shortens life expectancy, with some estimates putting this at around 10 years.8 Nearly 50% of patients diagnosed with RA suffer from mental health issues with 1 in 6 people having a major depressive disorder.6,9 RA is also a significant burden on the UK economy. Around a third of people diagnosed with RA stop work within two years of diagnosis10 and the combined cost of workdays lost due to osteoarthritis and RA in the UK was estimated at £2.58 billion in 2017 – estimated to rise to £3.43 billion by 2030.5

NICE guidance covers England. Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration. Filgotinib will be reviewed separately by the Scottish Medicines Consortium for use on the NHS in Scotland.

Under a new arrangement between Gilead and Galapagos, announced in December 2020, Galapagos will assume sole responsibility for filgotinib in Europe, including the UK. Through a phased transition the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021.

Source: Galapagos (Press release)