FDA approves BMS’s Zeposia for chronic inflammatory bowel disease
pharmafile | May 28, 2021 | News story | Medical Communications |
The FDA has approved Approves Bristol Myers Squibb’s Zeposia for adults with moderately to severely active ulcerative colitis (UC).
UC is a chronic inflammatory bowel disease and Zeposia is the first and only oral sphingosine 1-phosphate receptor modulator approved to treat it.
Zeposia demonstrated significant improvements across all primary and key secondary efficacy endpoints – including clinical remission, clinical response, endoscopic improvement, and endoscopic-histologic mucosal improvement – versus placebo in its Phase III study.
The mechanism by which Zeposia exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines. It is thought that by targeting S1P receptors on lymphocytes, a type of immune system cell, Zeposia reduces the number of lymphocytes in peripheral blood.
Adam Lenkowsky, General Manager and Head, US, Cardiovascular, Immunology and Oncology, Bristol Myers Squibb, said: “We’re thrilled that our pursuit of transformative science in immunology may benefit patients in their UC treatment by introducing a new option that has a different mechanism of action than available therapies.
“Zeposia combines disease control through lasting remission and demonstrated safety in a once-daily pill.”
Michael Osso, President & CEO of the Crohn’s & Colitis Foundation said: “UC can be debilitating and unpredictable for the people living with this chronic inflammatory bowel disease.”
“The approval of this new oral treatment is welcome news for our community and provides hope to many patients who are looking for new options to achieve symptom relief and remission.”
Lilly Subbotin
