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FDA Approves Higher-Dose Spinraza, Pricing Set at $152K

3/31/2026

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Summary

Story summary

The U.S. Food and Drug Administration (FDA) approved a higher-dose Spinraza regimen after a previous rejection.
The regimen includes two 50 mg doses 14 days apart, then a 28 mg maintenance dose every four months.
Biogen will price the 28 mg vial at $152,000 and the 50 mg vial at $271,000.
Trial data showed motor function improvement in infants.
Spinraza is approved in the European Union (EU), Switzerland, and Japan.

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Story summary

The U.S. Food and Drug Administration (FDA) approved a higher-dose Spinraza regimen after a previous rejection.
The regimen includes two 50 mg doses 14 days apart, then a 28 mg maintenance dose every four months.
Biogen will price the 28 mg vial at $152,000 and the 50 mg vial at $271,000.
Trial data showed motor function improvement in infants.
Spinraza is approved in the European Union (EU), Switzerland, and Japan.