Biogen scores FDA nod for Tecfidera follow-up Vumerity as MS threats linger

Biogen’s multiple sclerosis business has been treading water and its best-selling med, Tecfidera, might just run up against early generics. But now, the company has its next launch—and, it hopes, Tecfidera replacement—in the newly FDA-approved MS med Vumerity.

The Tecfidera follow-up won approval Wednesday, and Biogen touted it as a just-as-effective, better-tolerated version of its multibillion-dollar predecessor—and pharma watchers can expect the company to use that advantage to push patients toward the newer drug.

Vumerity “offers the well-characterized efficacy” of Tecfidera and “has been studied for improved patient-reported gastrointestinal tolerability,” Chief Medical Officer Alfred Sandrock said in a statement. 

The nod comes as Tecfidera, Biogen’s top drug by sales, battles new competitors, including Roche’s fast-launching MS star Ocrevus. And Tecfidera faces an intellectual property challenge from Mylan that could cut short its exclusivity. The key drug posted a 3% revenue increase in the third quarter to $1.12 billion.

As for the follow-up med, Bernstein analysts have said it will grow to $734 million by 2022 as Tecfidera sales shrink. 

With the approval, Biogen owes its partner Alkermes a $150 million milestone payment, and the biotech stands to collect a mid-teens royalty on global sales.