AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC
Betsy Goodfellow | May 31, 2024 | News story | Medical Communications | AbbVie, EMA, Gastrointestinal tract, Skyrizi, ulcerative colitis
AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to conventional or biologic therapy.
Treatment is recommended with an intravenous (IV) induction dose of 1200mg followed by a subcutaneous (SC) maintenance dose of either 180mg or 300mg, based on the individual patient presentation.
This positive opinion is based on data from two phase 3 trials, the INSPIRE induction trial and the COMMAND maintenance trial. INSPIRE assessed 1200mg of IV risankizumab as an induction dose at 0, 4 and 8 weeks in patients with moderately to severely active UC, whereas COMMAND evaluated patients who responded to this induction treatment, rerandomised to receive either 180mg or 360mg of SC risankizumab as maintenance doses for a further 52 weeks.
The drug’s safety profile remained consistent across both trials with the previously observed safety data, and no new safety risks were identified.
A final decision from the European Commission is expected during the third quarter of 2024.
Kori Wallace MD PhD, vice president of immunology clinical development at AbbVie, commented: “At AbbVie, patients are at the heart of everything we do. We are motivated to bring new treatment options to patients in need through our commitment to ongoing research and development in gastroenterology. We eagerly await the EMA’s final decision for risankizumab on its use in UC which has the potential to help patients meet their long-term treatment goals.”
Betsy Goodfellow
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