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May 27, 2021Zeposia Becomes First-in-Class Treatment for Ulcerative Colitis
May 27, 2021 – The U.S. FDA has approved a new indication for Zeposia ® (ozanimod), manufactured by Bristol Myers Squibb, to treat adults who have moderately to severely active ulcerative colitis (UC). First FDA approved in 2020, Zeposia is also indicated to treat multiple sclerosis. It is the first in a class of drugs called sphingosine 1-phosphate (S1P) receptor modulators approved to treat UC.
UC is a chronic autoimmune condition in which the immune system attacks tissue in the colon and rectum. This causes inflammation and ulcers, and can lead to abdominal pain, bloody stools, severe diarrhea, and a significant negative impact on a person’s quality of life. Though its mechanism of action in UC is not fully understood, Zeposia is thought to help treat the condition by reducing the number of lymphocytes (a type of immune cell) that reach the colon.
In a clinical trial, Zeposia induced clinical remission in 18% of patients (versus remission in 6% of patients on placebo) and a clinical response in 48% of patients (versus 26% on placebo). At week 52 of maintenance therapy, 37% of patients on Zeposia were in clinical remission versus 19% of patients receiving placebo, and 60% had a clinical response versus 41% on placebo.
Recommended dosing requires titration during a treatment induction phase lasting seven days. For Days 1-4 of induction, the recommended dose is 0.23mg taken by mouth once daily, then 0.46mg once daily on Days 5-7. Recommended maintenance dosing is 0.92mg once daily, starting on Day 8 of treatment.