Roche nabs a pri­or­i­ty re­view for Evrys­di, hop­ing to be­come the first oral treat­ment for in­fants with SMA

Roche has been duk­ing it out with Bio­gen and No­var­tis ever since burst­ing in­to the spinal mus­cu­lar at­ro­phy space about a year and a half ago with its com­pet­i­tive­ly priced oral treat­ment Evrys­di. Now the phar­ma gi­ant is look­ing to stake its claim in a younger sub­set of pa­tients — and the FDA has agreed to give it a speedy re­view.

Reg­u­la­tors have grant­ed pri­or­i­ty re­view to a sup­ple­men­tal NDA for Evrys­di (ris­diplam) to treat pre-symp­to­matic ba­bies un­der 2 months old with SMA. While the drug is cur­rent­ly ap­proved for adults, chil­dren and ba­bies old­er than 2 months, a new ap­proval here would make it the first at-home treat­ment avail­able for younger in­fants. A de­ci­sion is ex­pect­ed by May 30, ac­cord­ing to Roche.

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