Thursday, October 21, 2021

Bristol Myers’ multiple sclerosis drug Zeposia snags first-in-class nod to treat ulcerative colitis

Bristol Myers Squibb is already on a tough mission, trying to wedge Zeposia into the crowded multiple sclerosis market. Now, it has opened up a new, first-in-class front for the drug.

Zeposia snagged its FDA nod Thursday to treat moderate-to-severe active ulcerative colitis (UC), Bristol Myers said. It’ll go up against some of the giants in the immunology field—including AbbVie’s Humira—but as a pill, rather than an injectable, it has convenience on its side.

It marks the first time an S1P receptor modulator has branched out from multiple sclerosis (MS), an autoimmune disorder of the central nervous system, to inflammatory bowel disease. Novartis’ Gilenya and Mayzent belong to the same drug class.

Making that transition will require some commercial maneuvering. As Bernstein analyst Ronny Gal noted during a BMS conference call last month, there’s a general pricing gap between MS and UC drugs.

Still, BMS is pricing Zeposia at the same annualized wholesale acquisition cost—aka list price—of about $89,870 for the two indications, a company spokesperson said. BMS’ chief commercialization officer Chris Boerner said during the call that the company has “plans in place” about handling the pricing for Zeposia in UC.

The company could negotiate bigger discounts for payers in UC than in MS as a way to be more competitive without changing the list price.

RELATED: Doctors ‘highly positive’ on AbbVie’s Rinvoq in IBD, but not so much on Bristol Myers’ Zeposia: analyst

Currently, various types of injectable biologics are leading the UC market. These include TNF inhibitors such as AbbVie’s Humira; Takeda’s integrin therapy Entyvio; and Johnson & Johnson’s IL-12/23 antibody Stelara. Zeposia offers a new option for a growing pool of orals.

Zeposia proved its worth in UC in the phase 3 True North study. The drug showed better results across all primary and key secondary endpoints—including clinical remission, clinical response and endoscopic improvement—versus placebo at both Week 10 and Week 52.

The drug’s showing was “on par with a number of biologics,” and its efficacy was strong across patients who had previously used a biologic or had never before tried one, Mary Beth Harler, BMS’ head of immunology and fibrosis development, said in a recent interview.

“We believe that the balance of safety and efficacy in the phase 3 ulcerative colitis study for Zeposia will lead to this medicine playing an important role in the management of moderate to severe ulcerative colitis,” she said.

Zeposia will also compete against Pfizer’s oral JAK inhibitor Xeljanz. But the Pfizer drug’s being haunted by a heart safety problem, especially for a higher dose, leading to the FDA now taking a more cautious approach to the entire JAK class. The agency recently delayed decisions on AbbVie’s fellow JAK inhibitor Rinvoq in atopic dermatitis and psoriatic arthritis to review additional safety analyses.

RELATED: AbbVie’s Rinvoq rollout on track despite JAK safety concerns, but uncertainty remains: analyst

AbbVie recently reported two UC trial wins, in which Rinvoq was used at a 45-mg once-daily strength, three times that of its currently approved dosing in rheumatoid arthritis, which already bears a black box warning for blood clots.

Still, a recent physician survey by SVB Leerink suggested that JAK and S1P drugs will continue to gain traction, increasing their combined market share in UC to 25% by 2023 to 2024 from the current 17%.

While Zeposia’s now the first S1P drug to enter UC, competition is brewing. Arena Pharmaceuticals has etrasimod in the works. Compared with Zeposia, physicians liked the investigational drug better based on its phase 2 showing, according to SVB Leerink.

But as BMS’ Harler noted, the Arena drug has yet to report phase 3 data from a larger population. So, uncertainty remains as to how its phase 3 will play out against the earlier-stage data.

Arena in February completed enrollment in its phase 3 ELEVATE UC 52 trial for moderate to severe active UC and expects top-line data in the first quarter of 2022.

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