The U.S. Food and Drug Administration has approved a higher dose of Biogen's spinal muscular atrophy drug Spinraza, according to reports from Reuters. The approval comes after the regulator rejected the company's application last year, seeking revisions to the chemistry manufacturing and controls module in the application. The new regimen 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. This approval represents a significant milestone for Biogen as the company continues to expand its treatment options for spinal muscular atrophy and cutaneous lupus erythematosus while enhancing its pipeline with strategic partnerships.
As reported by Reuters, Biogen will introduce the 28 mg vial at a list price of about $152,000, same as that of the 12 mg vial, and the 50 mg vial at about $271,000. 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. The approval marks a boost for the U.S. drugmaker battling intensifying competition from therapies such as Roche's oral drug Evrysdi and Novartis's gene therapies Zolgensma and Itvisma. Biogen recently achieved significant milestones with FDA approvals and positive clinical trial results, positioning the company to focus on expanding its treatment options across multiple therapeutic areas.
According to Reuters, Biogen's shares rose 3.3% in morning trade following the FDA approval announcement. Jefferies analyst Andrew Tsai noted that the 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. The company's stock performance reflects investor confidence in the expanded treatment options and strategic pipeline enhancements, with Biogen maintaining its focus on developing innovative therapies across multiple therapeutic areas.
As reported by Reuters, Spinraza generated global sales of $1.55 billion last year, compared with $1.57 billion in 2024. The drug is used to treat spinal muscular atrophy, which affects nerve cells in the brain and spinal cord that control movement, as well as muscles used for speaking, walking, swallowing, and breathing. The 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. Biogen continues to compete in the spinal muscular atrophy market against therapies such as Roche's oral drug Evrysdi and Novartis's gene therapies Zolgensma and Itvisma.
