By Mariam Sunny and Kunal Das
March 30 (Reuters) – The U.S. 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 U.S. 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% in early trading.
The new regimen, which will be available in the U.S. 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 $1.55 billion last year, compared with $1.57 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.
Spinal muscular atrophy affects nerve cells in the brain and spinal cord that control movement, as well as muscles used for speaking, walking, swallowing, and breathing.
Biogen’s application was backed by mid-to-late-stage trial data that showed the higher-dose version significantly improved motor function in infants compared to untreated patients, with a safety profile similar to the low-dose regimen.
The drug is administered through an injection into the spinal fluid to boost protein levels essential for motor neuron survival and slow the progression of the disease.
(Reporting by Mariam Sunny and Kunal Das in Bengaluru; Editing by Shailesh Kuber and Sriraj Kalluvila)
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