Etrasimod NOW approved to treat patients (over the age of 16) with ulcerative colitis

March 29, 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine Etrasimod (Velsipity) on (11 March 2024) to treat people over the age of 16  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.

Treatment with Etrasimod is a long-term prescription and 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.

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).

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.” 

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.

Learn more at: Etrasimod approved to treat patients over the age of 16 with ulcerative colitis - GOV.UK (www.gov.uk)

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