FDA approves Zeposia for moderate-to-severe ulcerative colitis
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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.
Perspective
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Benjamin Cohen, MS, MAS
Previously approved for the treatment of multiple sclerosis, ozanimod is the first Sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of ulcerative colitis. It is thought to work by preventing lymphocyte egress from the lymph nodes to the blood stream. Phase 3 data from the True North program established its efficacy for the treatment of moderate to severe colitis compared with placebo and induction data recently presented at DDW 21 show symptomatic improvement as early as 2 weeks into treatment.
While there is an increasing number of therapies available for ulcerative colitis, many patients fail to respond or lose response to our existing therapies. Approval of a drug with a novel mechanism of action is a significant breakthrough for patients. It remains to be seen where ozanimod will fall in the treatment algorithm. Like other approved drugs, response to ozanimod is lower in patients with prior biologic failure. Additionally, while there was no significant safety signal in the clinical trials, safety concerns do exist.
Ozanimod may result in transient decreases in heart rate and atrioventricular conduction delays. Very low rates of bradycardia were observed in the clinical trials likely due to using a dose titration in the first week of treatment. However, pretreatment ECGs must be done in all patients and patients with QT prolongation, recent myocardial infarction, significant heart failure or history of heart block will need to consult a cardiologist prior to use. Asymptomatic liver enzyme elevations and rates of herpes zoster on par with approved biologic medications were also seen with ozanimod. One case of progressive multifocal leukoencephalopathy has been observed in MS patients treated with ozanimod, but none have occurred in ulcerative colitis patients. Other pretreatment assessments and monitoring recommendations prescribers must be aware of are detailed in the approved labeling. While ozanimod is a non-selective S1P receptor modulator, clinical trials are ongoing with more selective S1P modulators to determine if increased selectivity will have safety or efficacy benefits. We will continue to learn more about ozanimod’s safety and efficacy through real world post-approval studies.
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