New FDA Approvals: FDA Approves Evrysdi in Tablet Formulation
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Mar 13, 2025
Feb. 11: The FDA approved a new tablet formulation of Roche Group subsidiary Genentech USA, Inc.’s Evrysdi (risdiplam) for the treatment of spinal muscular atrophy in people at least 2 years old who weigh at least 20 kg. The agency first approved the survival of motor neuron 2 (SMN2) splicing modifier on Aug. 7, 2020, as an oral solution; that formulation remains available. Dosing for the tablet is 5 mg once daily. Drugs.com lists the price of 60 mg of oral powder (0.75 mg/mL solution) as more than $14,062.
Feb. 12: The FDA expanded the label of Astellas Pharma Inc.’s Izervay (avacincaptad pegol) to remove the 12-month limit on treatment duration for the treatment of geographic atrophy secondary to age-related macular degeneration (AMD). The agency first approved the complement C5 inhibitor on Aug. 4, 2023. Dosing is 2 mg administered by intravitreal injection to each affected eye once monthly without a limitation on duration of dosing. The drug’s list price per single-dose vial is $2,100.
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