Zeposia is claimed to be the first and only S1P receptor modulator approved for treating moderately to severely active UC
Entrance to the Bristol-Myers Squibb building at 100 Nassau Park Boulevard. (Credit: Jonathan Schilling/Wikipedia.)
Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Zeposia (ozanimod) to treat a type of ulcerative colitis (UC).
The FDA indicated the drug in 0.92mg dose to treat adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).
Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5, used as once-daily oral medication.
The US drugmaker claimed that its Zeposia is the first and only S1P receptor modulator approved for treating moderately to severely active UC.
The drug exerts therapeutic effects thorough an unknown mechanism, but targets S1P receptors on lymphocytes to reduce their migration into the intestines.
Zeposia has received the US FDA approval to treat relapsing forms of multiple sclerosis (RMS) in March, and European Commission (EC) approval to treat relapsing remitting multiple sclerosis (RRMS), in May last year.
Bristol Myers Squibb general manager and US cardiovascular, immunology and oncology head Adam Lenkowsky said: “Despite the availability of approved therapies, there is still unmet need and an opportunity to deliver additional treatment options to help patients better manage their disease.
“We’re thrilled that our pursuit of transformative science in immunology may benefit patients in their ulcerative colitis 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.”
FDA approved Zeposia based on phase 3 True North trial data
The US FDA approval is based on data from True North, a Phase 3, multicentre, randomised, double-blind, placebo-controlled clinical trial.
The True North trial evaluated the efficacy and safety of Zeposia in patients with moderately to severely active UC, with inadequate response to oral aminosalicylates, corticosteroids, immunomodulators or a biologic, compared to placebo.
The clinical trial met its primary endpoint of clinical remission, along with key secondary endpoints including clinical response, endoscopic improvement and endoscopic-histologic mucosal improvement, at week 10 and week 52.
Also, patients treated with Zeposia experienced decrease in their rectal bleeding and stool frequency subscores, as early as second week.
Swedish Medical Centre IBD Center co-director Michael Chiorean said: “In True North, Zeposia demonstrated efficacy for endpoints such as clinical remission, endoscopic and histological mucosal improvement and safety. All are very relevant considerations for patients with ulcerative colitis.
“Zeposia has the potential to be an important new treatment option for adult patients with moderate to severe ulcerative colitis.”
Furthermore, BMS has filed an EU Marketing Authorization Application for Zeposia with current indication, which is under review with the European Medicines Agency (EMA).