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

The approval for the potentially more effective treatment is a boost for the US drugmaker, which is battling intense competition from therapies such as Roche’s oral drug Evrysdi and Novartis’ gene therapies Zolgensma and Etvisma.

Shares of Biogen rose 3.3% in morning trading.

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

Biogen will offer a list price of about $152,000 for the 28 mg vial, the same as the 12 mg vial, and about $271,000 for the 50 mg vial, a company spokeswoman said.

Higher-dose Spinraza could address the diminishing effect experienced by patients with faster loading doses, which could better position Biogen to enter the adult population and drive potential growth through 2026, Jefferies analyst Andrew Tsai said.

Spinraza generated global sales of $1.55 billion last year, up from $1.57 billion in 2024.

The regulator last year refused to approve the company’s application, seeking amendments to the chemical production and control module in the application.

Spinal muscular atrophy affects the nerve cells in the brain and spinal cord that control movement, as well as the muscles used for talking, walking, swallowing, and breathing.

Biogen’s application was supported by mid-to-late-phase trial data showing that the high-dose regimen significantly improved motor function in infants compared to untreated patients, with a safety profile similar to the low-dose regimen.

The drug is given by injection into the spinal fluid to increase protein levels necessary for motor neuron survival and slow the progression of the disease.