Levi Garraway, Roche CMO (Source: Genentech)
FDA hands out a quick OK for potential SMA blockbuster risdiplam, giving Genentech and Roche a chance to challenge rivals on the price
US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.
The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.
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