CHMP recommends Velsipity (etrasimod) for the treatment of ulcerative colitis – Pfizer

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Velsipity, intended for the treatment of ulcerative colitis.

The applicant for this medicinal product is Pfizer Europe. Velsipity will be available as a 2 mg film-coated tablet. The active substance of Velsipity is etrasimod, a selective immunosuppressant (ATC code: L04AE05). The mechanism by which etrasimod exerts therapeutic effects in ulcerative colitis is unknown, but it may involve the reduction of lymphocyte migration into sites of inflammation, as selective binding of etrasimod to S1P receptors 1,4 and 5 partially and reversibly blocks the capacity of lymphocytes to egress from lymphoid organs.

The benefits of Velsipity are the achievement of remission of ulcerative colitis in patients with moderate to severe disease, normalizing stool frequency and rectal bleeding and inducing endoscopic healing. Efficacy was demonstrated in two phase III randomised, double-blind, and placebo-controlled studies. The most common side effects are lymphopenia and headache.