Biogen’s latest blockbuster gets a reprieve

Thanks to the FDA, Novartis is unlikely to expand the market for Zolgensma, its gene therapy for spinal muscular atrophy, until 2023. That’s a disappointment for patients, but it's good for the balance sheet at Biogen, whose own SMA therapy, Spinraza, has been among the sole bright spots in recent years.

The news is that the FDA wants Novartis to run another clinical trial on Zolegensma’s effects on patients over the age of 2, an indication for which Biogen’s treatment is already approved. That should ease the competitive pressure on Spinraza, which currently contends with Zolgensma and a daily oral treatment from Roche that won approval for SMA patients of any age last month.

And the reprieve comes at an opportune time. Biogen’s best-selling drug, the multiple sclerosis treatment Tecfidera, is soon to face a multitude of generics, imperiling a treatment that accounts for nearly a quarter of the company’s revenue. Less competition for Spinraza, which brought in $2 billion last year, gives Biogen some extra breathing room in the meantime.