The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has granted AbbVie’s ulcerative colitis (UC) drug Skyrizi (risankizumab) a positive recommendation for approval.

The committee’s recommendation was based on results from two Phase III studies. In the INSPIRE trial (NCT03398148), 20.3% of patients in the Skyrizi treatment group achieved clinical remission, compared to 6.2% in the placebo group. Furthermore, in the Phase III COMMAND study (NCT03398135), 51% of patients treated with Skyrizi 180 mg and 48% of patients treated with Skyrizi 360mg demonstrated endoscopic improvement in week 52. Skyrizi is a monoclonal antibody therapy that inhibits interleukin-23 (IL-23). This reduces anti-inflammatory processes.

In the 31 May press release, Dr Edouard Louis, the head of gastroenterology at University Hospital CHU of Liège Belgium said: “These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and faecal incontinence.”

The US Food and Drug Administration (FDA) previously approved Skyrizi for the treatment of Crohn’s disease, psoriatic arthritis, and plaque psoriasis. The EMA has also approved the treatment for the same conditions.

This CHMP decision arrives as AbbVie recovers from losses in sales for its blockbuster immunology drug Humira (adalimumab). The drug’s US patent expired in January 2023 and its EU counterpart expired in 2018, opening up the market to competitors. These events coincided with a 7% fall in Abbvie’s revenue for 2023.

However, the company has continued in its efforts to bolster its immunology pipeline. Alongside Skyrizi, Abbvie has also developed the Janus kinase inhibitor Rinvoq (upadacitinib) for the treatment of several autoimmune diseases. Last year, the FDA awarded Rinvoq its seventh labelled indication since its first US approval in 2019. Furthermore, in 2024, the company signed deals with Tentarix and Landos Biopharma to continue its immunology drug development.

GlobalData consensus forecasts predict that global sales for Skyrizi could reach $19.6bn in 2030, with Rinvoq approaching a potential $12.2bn in the same year.

https://www.pharmaceutical-technology.com/news/ema-endorses-abbvies-skyrizi-for-ulcerative-colitis/?cf-view