Etrasimod approved to treat patients over the age of 16 with ulcerative colitis
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine etrasimod (Velsipity) to treat people with moderately to severely active ulcerative colitis.
Ulcerative colitis is a long-term condition where the colon and rectum become inflamed. Small ulcers can develop on the colon’s lining and can bleed and produce pus.
The main symptoms of ulcerative colitis are recurring diarrhoea, which may contain blood, mucus or pus, stomach pain and increased stool frequency. Patients may also experience extreme tiredness (fatigue), loss of appetite and weight loss.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us.
We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.
As with all products, we will keep its safety under close review.”
Etrasimod is a long-term prescription medicine and treatment should only be started under the supervision of a doctor who is experienced in treating ulcerative colitis.
The recommended dose of etrasimod is one 2 mg tablet taken once daily. Etrasimod should be taken with food for the first 3 days. After this, etrasimod can be taken each day with or without food.
Etrasimod prevents lymphocytes (a type of white blood cell) from travelling from the lymph nodes (part of the body’s immune system that contains lymphocytes) into the blood. These Iymphocytes are involved in the immune response and inflammation that is linked to the development of ulcerative colitis. By reducing the number of lymphocytes circulating in the blood surrounding the large intestine, etrasimod helps to reduce bowel inflammation and the symptoms associated with the disease.
This regulatory approval is supported by evidence from two randomised, double-blind, placebo-controlled clinical studies (ELEVATE UC 52 and ELEVATE UC 12) involving 743 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.
Taken together, the results from the two studies showed that, after 12 weeks of treatment, 26% (129 out of 496) of those who received etrasimod had achieved clinical remission compared with 11% (27 out of 247) of those who received placebo.
One of these studies also looked at the longer-term effect of treatment and found that 32% (88 out of 274) of people taking etrasimod achieved clinical remission after 52 weeks compared with 7% (9 out of 135) for those receiving placebo.
The most common side effects of the medicine are bradycardia (slow heart rate), hypertension (high blood pressure), urinary tract infection (infection of parts of the body that collect and pass out urine) and lower respiratory tract infection (infection of the lower airways or lungs).
As with any medicine, the MHRA will keep the safety and effectiveness of etrasimod under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
- The new marketing authorisation was granted on 11 March 2024 to Pfizer
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- This was a randomised, double-blind clinical trial, where neither the participants nor the staff on the trial were aware of were aware of what each participant was taking. For more information about the studies, see the Summary of Product Characteristics.
- For more information about ulcerative colitis, visit: https://www.nhs.uk/conditions/ulcerative-colitis/
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.