ZEPOSIA® (ozanimod) - FDA-Approved for Ulcerative Colitis

S1P=sphingosine 1-phosphate.

^aStudy Design: 2 multicenter, randomized, double-blind, placebo-controlled studies in adult patients with moderately to severely active UC, UC Study 1 (induction 10 weeks, N=645) and UC Study 2 (maintenance 42 weeks, N=457). In both studies, patients were randomized to either once-daily ZEPOSIA 0.92 mg or placebo. To enter UC Study 2, patients had to have received ZEPOSIA in either UC Study 1 or in an open-label arm and be in clinical response (defined as a reduction from baseline in the 3-component Mayo score of ≥2 points and ≥35% and a reduction from baseline in the rectal bleeding subscore [RBS] of ≥1 point or an absolute RBS of 0 or 1) at Week 10. Primary Endpoint: Percent of patients in clinical remission at Weeks 10 and 52. ZEPOSIA 18% vs placebo 6% (p<0.0001) and 37% vs 19% (p<0.0001), respectively.¹

^bClinical Remission Is Defined as: RBS=0, stool frequency subscore (SFS) 0 or 1 (and a decrease of ≥1 point from the baseline of SFS), and endoscopy subscore 0 or 1 without friability.¹

^cZEPOSIA has been studied across multiple indications in 4 clinical trials including TRUE NORTH (NCT02435992), a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial; TOUCHSTONE (NCT01647516), a randomized, double-blind, placebo-controlled phase 2 clinical trial; and SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), 2 multicenter, randomized, double-blind, double-dummy, active treatment-controlled phase 3 clinical trials. 496 patients receiving the 0.92-mg dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92-mg dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis.¹

ECG=electrocardiogram; VZV=varicella-zoster virus.

^dHome visits for initial routine medical tests are not available to people enrolled in Medicare, Medicaid, or other federal or state healthcare programs, or to people living in Rhode Island.

^eThe Bridge Program is available at no cost for eligible commercially insured, on-label diagnosed patients if there is a delay in determining whether commercial prescription coverage is available, and is not contingent on any purchase requirement, for up to 24 months (dispensed in 30-day increments). The Bridge Program is not available to patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state program, or MI residents, and is available for no more than 12 months to patients in MA, MN, and RI. Appeal of any prior authorization denial must be made within 90 days or as per payer guidelines, to remain in the Program. Eligibility will be re-verified in January for patients continuing into the following year, and may be at other times during Program participation. Offer is not health insurance, and may be modified or discontinued at any time without notice. Once coverage is approved by the patient’s commercial insurance plan, the patient will no longer be eligible. Other limitations may apply.

^fDepending on insurance coverage and where the full cost is not covered by patient's insurance, eligible patients may receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription, as well as a medical assessment benefit offer for out-of-pocket costs for the initial blood tests, ECG screening, and eye exam. Maximum savings limit applies; patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please click here for Program Terms, Conditions, and Eligibility Criteria.

Reference: 1. ZEPOSIA. Prescribing Information. Bristol-Myers Squibb Company; 2021.