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

Biogen on Wednesday scored FDA approval for new MS offering Vumerity. (Biogen)

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


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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.  

RELATED: Still reeling from aducanumab flop, Biogen executives lay their cards on the table 

Vumerity will be one of Biogen's most important new drugs, but the approval news pales alongside the bombshell Biogen dropped last week when it revived Alzheimer’s candidate aducanumab. A futility analysis this spring determined the drug wouldn’t help patients, but Biogen now says a new analysis of a larger dataset sets the drug up for a potential FDA approval. The drugmaker is now in talks with the agency and working on a filing.

Just how the effort will play out remains to be seen—after previous data disappointments, some analysts are wary—but excited investors drove shares up by 26% on the news.

Outside of MS and Alzheimer's disease, Biogen's spinal muscular atrophy drug Spinraza has surpassed early expectations, but it's facing a threat from Novartis' new gene therapy Zolgensma and a potential entrant in Roche and PTC Therapeutics' risdiplam. 

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