NICE issues FAD backing Stelara for active ulcerative colitis

28 April 2020

Reversing a negative decision in January this year, the UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Stelara for ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if:

a tumor necrosis factor (TNF)-alpha inhibitor has failed (that is the disease has responded inadequately or has lost response to treatment);
a TNF-alpha inhibitor cannot be tolerated or is not suitable.

Stelara is marketed by Janssen, the pharmaceutical business of US healthcare giant Johnson & Johnson (NYSE: JNJ), and is already recommended by the NICE as a clinical and cost-effective option for the treatment of plaque psoriasis, psoriatic arthritis and CD. The drug generated total global sales of $6.36 billion for the full year 2019, up 23% on 2018.

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