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


Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

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. 

Suggested Articles

Amid Amgen's pricing war with Sanofi and Regeneron's Praluent, PCSK9 cholesterol fighter Repatha has shown a clinical benefit for HIV patients.

A month after the FDA approved it, Esperion's Nexletol showed it can lower cholesterol regardless of statin and ezitimibe treatment.

AstraZeneca's Farxiga can help prevent worsening or death in heart failure patients regardless of other therapies received, according to new data.