Biogen gets FDA approval for higher dose of genetic disorder drug

BENGALURU: The US Food and Drug Administration has approved a higher dose of Biogen’s spinal muscular atrophy drug Spinraza, the company said on Monday, after rejecting it last year.

The approval for a potentially more effective treatment marks a boost for the US drugmaker battling intensifying competition from therapies such as Roche’s oral drug Evrysdi and Novartis’ gene therapies Zolgensma and Itvisma.

Biogen’s shares rose 2.3 percent in early trading.

The new regimen, which will be available in the US in the coming weeks, uses two 50 milligram initial doses given 14 days apart, followed by a 28 mg maintenance dose every four months, compared to the current standard dose of 12 mg.

Biogen will introduce the 28 mg vial at the same price as the 12 mg vial, a company spokesperson said, without offering further details.

Higher-dose Spinraza could address the waning-off effect experienced by patients with a more rapid loading dose, which could better position Biogen to penetrate the broader adult population and potentially drive growth from 2026 onwards, said Jefferies analyst Andrew Tsai.

Spinraza generated global sales of USD1.55 billion last year, compared with USD1.57 billion in 2024.

The regulator had declined to approve the company’s application last year, seeking revisions to the chemistry manufacturing and controls module in the application.