FDA approves Zeposia for moderate-to-severe ulcerative colitis
The FDA has approved Zeposia 0.92 mg for the treatment of moderate-to-severe ulcerative colitis.
Zeposia (Ozanimod, Bristol Myers Squibb), the first sphingosine 1-phosphate (S1P) receptor modulator approved for moderate-to-severe active UC, may reduce the lymphocyte migration into the intestines, according to the press release.
The approval is based on results from True North, a phase 3 trial that assessed ozanimod as an induction and maintenance therapy compared with placebo in patients with moderate-to-severe active UC (ozanimod n = 429 vs. placebo n = 216).
At 10 weeks, the trial met its primary endpoint of clinical remission (18% vs. 6%; P < .0001), as well as its secondary endpoints of endoscopic improvement (48% vs. 26%; P < .0001), and endoscopic-histological improvement (48% vs. 26%; P < .0001) for ozanimod vs. placebo. During maintenance at 52 weeks (ozanimod n = 230 vs. placebo n = 227), clinical remission was also met (37% vs. 19%; P < .0001), according to the release.
“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,” Michael Chiorean, MD, AGAF, FASGE, co-director of IBD Center, Swedish Medical Center in Seattle, Washington, said in the release. “Zeposia has the potential to be an important new treatment option for adult patients with moderate to severe ulcerative colitis.”
Bristol Myers Squibb developed the Zeposia 360 Support program to ensure ozanimod was assessable for patients who need it, according to the release. It offers a co-pay program for eligible patients to pay as little as $0 for their prescription, assistance with financial support and may help eligible patients with commercial insurance to receive free medication if they are experience delays or issues with insurance coverage.
In the European Union, t the European Medicines Agency is currently reviewing a marketing authorization application. Bristol Myers Squibb anticipates a regulatory decision in the second half of 2021.