Bristol Myers Squibb notched a big win with its recent approval of multiple sclerosis drug Zeposia, a Celgene pipeline pickup with blockbuster aspirations. Not content to ride its way to success in MS alone, Zeposia is gunning for an approval in the massive ulcerative colitis market––and promising late-stage data will likely help its case.
Daily Zeposia significantly increased the number of patients who achieved remission from ulcerative colitis symptoms over placebo at 10 weeks and helped maintain remission through 52 weeks, according to top-line data from the phase 3 True North trial released Tuesday.
Zeposia, which hit the market for the first time Monday in multiple sclerosis, is hoping to become the first oral sphingosine-1-phosphate (S1P) receptor modulator approved to treat ulcerative colitis, Bristol said in a release.
The company is hoping that Zeposia will provide a fresh option in the jam-packed ulcerative colitis market dominated by older meds, such as anti-TNF inhibitor Humira, and a JAK inhibitor class plagued by safety issues.
But meanwhile, a suite of next-gen drugs is also angling for share of the lucrative indication, with its roughly 910,000 U.S. patients each year.
RELATED: Bristol Myers Squibb’s Zeposia launches into crowded MS market
In October, Johnson & Johnson stalwart Stelara received an FDA approval to treat ulcerative colitis, adding to a growing list of major players in the indication.
That list includes Pfizer’s Xeljanz, a drug with troubled recent history. In July, Xeljanz was hobbled by an FDA black box warning for an increased risk of blood clots and a decree from the agency that the drug be used only in ulcerative colitis patients who don’t respond to or aren’t suited for other meds.
While the cardiovascular risks showed up in rheumatoid arthritis patients taking the 10-mg dose in a postmarketing study, the FDA argued they “may also apply to those taking [Xeljanz] for ulcerative colitis.” The 10 mg dose is only approved in colitis patients.
RELATED: AbbVie’s Rinvoq label portends safety warnings for future JAKs—including Gilead’s
But those safety warnings aren’t limited to Xeljanz alone. In August, the FDA slapped a black-box warning on the label of AbbVie’s JAK inhibitor Rinvoq, a crucial Humira follow-up drug, cautioning patients of an increased risk of serious infections, malignancy, and thrombosis. Rinvoq is currently approved to treat rheumatoid arthritis alone but is pursuing FDA approvals in a wide swatch of indications, including ulcerative colitis.
Meanwhile, Rinvoq’s label doesn’t bode well for future next-gen JAK inhibitors aiming for blockbuster sales. A prime example: Gilead Sciences’ filgotinib, which was filed for approval in rheumatoid arthritis in December and posted phase 3 ulcerative colitis data last month.
