Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors


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

Written by | 21 Dec 2023 | Gastroenterology

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.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.


You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.