NICE backtracks to approve Janssen’s Stelara in ulcerative colitis
pharmafile | April 28, 2020 | News story | Manufacturing and Production, Research and Development | Janssen, NICE, Stelara, ulcerative colitis
NICE has recommended Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis (UC), a move which rows back on the Institute’s decision to reject the drug last year.
The approval for use on the NHS in England and Wales covers adult patients who cannot tolerate conventional therapy or a biological agent. It can also be used for patients who have not responded to treatment when they have previously failed to respond to a tumour necrosis factor (TNF)-alpha inhibitor, or for whom they are not suitable.
UC affects around 146,000 patients in the UK, and there is currently no cure for the disease.
Phase 3 data in support of the ruling showed that 44% and 38% of two patient groups randomised to receive Stelara subcutaneously achieved clinical remission after 44 weeks of treatment, compared to just 24% with placebo. All patients across these groups had responded to Stelara in a previous study.
“Ulcerative colitis can have a devastating impact on the lives of those living with this longterm condition. A flare up of symptoms can be incredibly debilitating, preventing people getting on with normal day-to-day life and work,” commented Professor James Lindsay, Consultant Gastroenterologist at Barts Health NHS Trust in London. “Many patients do not respond to, or get side-effects from, currently available therapies. Therefore, the recent NICE approval for ustekinumab as a novel therapy for patients that are not suited to currently available treatments is welcome.”
This latest NICE approval for Stelara follows those in plaque psoriasis, psoriatic arthritis and Crohn’s disease. The drug is expected to be available on the NHS within three months of the health service’s receipt of a final Technology Appraisal Guidance, due to be published in June this year.
Matt Fellows
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