“As of 2015, approximately 3 million people in the United States have inflammatory bowel disease, which includes ulcerative colitis and Crohn’s disease.7 The needs of the ulcerative colitis patient community were squarely at the center of our pursuit of transformative science in this condition,” said Tina Deignan, vice president and U.S. head of Immunology, Bristol Myers Squibb.
Zeposia is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for UC and works differently than available therapies.6 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.6,8,9
“This approval marks the first time Bristol Myers Squibb Immunology has offered a gastrointestinal disease treatment. We’re thrilled to introduce Zeposia, a new option for UC that combines disease control through lasting remission and demonstrated safety in a once-daily pill,6” said Deignan.
Zeposia is contraindicated in patients who in the last six months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker; patients with severe untreated sleep apnea; and patients taking a monoamine oxidase (MAO) inhibitor. Zeposia is associated with the following Warnings and Precautions: increased risk of infections, bradyarrhythmia and atrioventricular conduction delays, liver injury, fetal risk, increased blood pressure, respiratory effects, macular edema, posterior reversible encephalopathy syndrome (PRES), unintended additive immunosuppressive effects from prior immunosuppressive or immune-modulating drugs, and severe increase in disability and immune system effects after stopping Zeposia. Please see Important Safety Information for additional details. The most common adverse reactions (incidence ≥ 4%) were liver test increased, upper respiratory infection, and headache.6
The approval is based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC. During induction at Week 10 (Zeposia N=429 versus placebo N=216) the trial met its primary endpoint of clinical remissiona (18% versus 6%, p<0.0001) as well as key secondary endpoints, including clinical responseb (48% versus 26%, p<0.0001), endoscopic improvementc (27% versus 12%, p<0.0001) and endoscopic-histologic mucosal improvementd (13% versus 4%, p<0.001) for Zeposia versus placebo, respectively. During maintenance at Week 52 (Zeposia N=230 versus placebo N=227) the trial met its primary endpoint of clinical remissiona (37% versus 19% p<0.0001) as well as key secondary endpoints, including clinical response (60% versus 41%, p<0.0001), endoscopic improvement (46% versus 26%, p<0.001), corticosteroid-free clinical remissione (32% versus 17%, p<0.001) and endoscopic-histologic mucosal improvement (30% versus 14%, p<0.001) for Zeposia versus placebo, respectively. Additionally, decreases in rectal bleeding and stool frequency subscores were observed as early as Week 2 (i.e., 1 week after completing the required 7-day dosage titration) in patients treated with Zeposia.6
Deignan adds, “We are committed to making this therapy accessible to the patients who need it.”
She explains that eligible patients can take part in the Zeposia 360 Support™ program, which will facilitate access to Zeposia for appropriate patients with UC. This includes a co-pay program for eligible appropriate patients to pay as little as $0 for their Zeposia prescription, assistance with financial support and a program that may help eligible patients with commercial insurance to receive free medication while they are experiencing delays or issues with insurance coverage. Support for eligible patients is also available for the routine initiation assessments, such as lab work. Through the program, health care professionals can opt to have eligible patients receive these tests in their own homes. These costs, whether incurred at home or in office, may be reimbursed. Terms, conditions, and eligibility criteria apply.
For more information on Zeposia and the Zeposia 360 SupportTM program, visit Zeposia.com.