Roche: FDA approves new formulation of Evrysdi
(CercleFinance.com) - Roche announces that the FDA has approved a new tablet formulation of Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA).
The 5 mg tablet, which can be swallowed whole or dissolved in water, offers a convenient alternative to the existing oral solution.
Its approval is based on a bioequivalence study demonstrating comparable efficacy and safety.
The tablet will be available in the coming weeks for patients aged two and over and weighing more than 20 kg.
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