NICE approves AbbVie's Skyrizi for ulcerative colitis

The UK's National Institute for Health and Care Excellence (NICE) has released final guidance endorsing AbbVie's medication Skyrizi (risankizumab) as a therapeutic option for adults suffering from moderately to severely active ulcerative colitis (UC) in England and Wales. This recommendation closely follows the expanded approval given to the medication earlier in the week by the Medicines and Healthcare Products Regulatory Agency (MHRA).

Skyrizi, an IL-23 inhibitor, is now advised for UC patients who either cannot tolerate or have not responded to conventional, biological, or TNF-alpha inhibitor treatments, or for whom TNF-alpha inhibitors are not suitable. The endorsement from NICE is bolstered by findings from the Phase III INSPIRE induction and COMMAND maintenance trials. Both trials achieved their primary goal of clinical remission and also met crucial secondary endpoints, such as endoscopic improvement and histologic-endoscopic mucosal improvement.

In the pharmaceutical market, Skyrizi is on track to surpass Humira (adalimumab) as AbbVie's leading product. In the second quarter, Skyrizi's sales surged nearly 45% to $2.7 billion, while Humira's sales fell by almost 30% to $2.8 billion due to competition from biosimilars.

A recent survey conducted by FirstWord, which involved 46 gastroenterologists based in Europe, revealed that 80% of the doctors are likely to prescribe Skyrizi for moderate-to-severe UC. The primary reason cited by 78% of the respondents for the drug's adoption was its effect on clinical remission.

Skyrizi received the UC indication from the FDA in June, followed by approval from EU regulators approximately a month later.

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