In a news release from biopharmaceutical company Bristol Myers Squibb, the company shared that the FDA accepted its supplemental New Drug Application (sNDA). Because the sNDA was submitted alongside a Priority Review voucher, the FDA will respond to the sNDA by May 30. Overall, the application focuses on Zeposia (ozanimod) for adult patients with moderate-to-severe ulcerative colitis (UC).
The data submitted with the sNDA focuses on the Phase 3 True North clinical trial, which evaluated the safety, efficacy, and tolerability of Zeposia in patients with UC. Trial participants did not respond to previous treatment. In the induction phase, a majority of patients were male with a mean age of 42. Patients received either a placebo or 1mg Zeposia for a 10-week period. A second cohort took part in an open-label arm of the trial, in which patients received 1mg Zeposia daily for 10 weeks.
In the maintenance phase, patients who reached a clinical response during the first part of the trial then received either Zeposia or a placebo for an additional 42 weeks (to reach 52 weeks in total). For the most part, the drug was safe and well-tolerated. The clinical trial also reached its primary endpoints of clinical remission, and showed patient health improvements.
Zeposia is an orally administered sphingosine-1-phosphate (S1P) receptor modulator. Normally, lymphocytes, a type of white blood cell involved in immune function, may cause additional pain and inflammation in patients with UC. This is because the lymphocytes move into the inflamed mucosa. However, Zeposia prevents some lymphocytes from circulating.
Patients taking a MAO inhibitor, who have prior heart issues, who are pregnant or planning to become pregnant, or who have sleep apnea, should not take Zeposia. Although the drug is relatively well-tolerated, symptoms and adverse reactions may include:
- Frequent infections
- Herpes zoster
- Elevated minotransferases
- Back pain
- Urinary tract infections
- High blood pressure
- Low heart rate
- Macular edema
- Disease exacerbation (upon stopping Zeposia)
Ulcerative Colitis (UC)
An estimated 700,000 Americans have ulcerative colitis (UC), a chronic inflammatory disorder characterized by large intestine sores and ulcers. People of Jewish heritage, with a family history of UC, or who are either young adults or over 60 years old are most at risk of developing UC. The exact cause of UC is unknown. However, some medical professionals believe an overactive or malfunctioning immune system causes UC. Some patients experience mild inflammation while for others, this condition can be severe and debilitating. Symptoms include:
- Bloody stool
- Unintended weight loss
- Anemia (low red blood cell count)
- Nausea and abdominal cramping
- Loose bowel movements
- Joint pain
- Rectal pain and bleeding
- Urgent need to defecate
- Failure to thrive (in children)