Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

Velsipity (etrasimod – Pfizer) tablets were approved by the U.S. Food and Drug Administration (FDA) on Oct. 13, 2023. The sphingosine 1-phosphate receptor (S1P) modulator is indicated to treat adults who have active ulcerative colitis (UC) that is moderate to severe. The recommended dosing is 2mg once daily. The company is planning on launching Velsipity in late November with a wholesale acquisition cost (WAC) of about $6,100 for 30 tablets. It will be available through open distribution. Look here for its complete prescribing information.

At a Glance

  • Brand (Generic) Name: Velsipity (etrasimod)
  • Manufacturer: Pfizer
  • Date Approved: Oct. 13, 2023
  • Indication: the treatment of moderately to severely active ulcerative colitis in adults
  • Dosage Forms Available: 2mg oral tablets
  • Launch Date: Late November 2023
  • Estimated Annual Cost: WAC of $75,000
  • UC is an autoimmune inflammatory bowel disease (IBD) that damages the lining of the large intestine and rectum.
  • According to the Crohn’s and Colitis Foundation, more than 900,000 patients in the U.S. have UC, and about 38,000 new patients are diagnosed, annually.
  • Although most cases are discovered for individuals between 15 and 35 years of age, men have a secondary spike in diagnoses after the age of 50.
  • In general, UC is more common among people who live in cities of industrialized countries in the northern hemisphere.
  • Other risk factors for IBDs include smoking and taking certain medications, such as antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). Certain foods may trigger symptoms in some patients.
  • Many symptoms of IBDs, such as fatigue, fever, and weight loss, can be vague and general. More specific symptoms can include rectal bleeding and the feeling that the bowels have not emptied fully. The severity of symptoms also tends to be irregular and unpredictable.
  • By lowering the amount of lymphocytes in the blood, Velsipity is believed to reduce inflammation in the intestines.
  • In the ELEVATE UC52 clinical study, 27% of patients previously treated with at least one other therapy for UC had a remission in UC symptoms after 12 weeks of treatment with Velsipity. Only 7% of patients taking a placebo went into remission. By one year, the percentage had risen to 32% for actively treated patients, but it remained 7% for those taking a placebo.
  • Taking Velsipity may increase the risk of having infections, so a complete blood count (CBC) should be done before starting the medication. Patients should be checked for infections periodically while taking it and for about 90 days after they stop it.
  • Since it may affect heart and liver function, patients using Velsipity need regular cardiac and hepatic evaluations, as well.
  • Several other therapy classes, such as antibiotics, corticosteroids, immunomodulators, and 5-aminosalicylic acids (5-ASAs), are used to treat UC. Tumor necrosis factor (TNF) blockers, including adalimumab (Humira®/biosimilars) also are used, as are Entyvio® (vedolizumab) and Tysabri® (natalizumab), which prevent certain types of white blood cells from increasing intestinal inflammation.
  • One other S1P inhibitor, Bristol Myers Squibb’s Zeposia® (ozanimod) capsules, has been FDA-approved for treating UC since May 2021. It needs the same precautions for side effects as Velsipity and it must be increased slowly to the maintenance dose to reduce the chance of decreased heart rate.