MHRA approves Pfizer’s Velsipity to treat people with ulcerative colitis

Studies showed that 26% of those who received the once-daily tablet achieved clinical remission after 12 weeks of treatment.   

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis.

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum.

The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food.

According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, 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,” she added.

The MHRA, however, cautioned that etrasimod is a long-term prescription medicine and it should only be given under the supervision of a doctor who is experienced in treating ulcerative colitis.

How the medicine works  

Etrasimod reduces the number of lymphocytes (a type of white blood cell) circulating in the blood surrounding the large intestine, thereby helping to alleviate bowel inflammation and the symptoms associated with the disease.

Symptoms of ulcerative colitis to watch out for

Ulcerative colitis can cause recurring diarrhoea, possibly containing blood, mucus or pus, stomach pain and increased stool frequency. Additionally, patients may experience extreme tiredness (fatigue), loss of appetite and weight loss.