Roche wins new Evrys­di ap­proval for the youngest SMA pa­tients

Roche just turned the spinal mus­cu­lar at­ro­phy race up an­oth­er notch.

The Big Phar­ma com­pa­ny won an­oth­er FDA ap­proval for its oral SMA drug Evrys­di, though Tues­day’s green light comes for ba­bies younger than two months old. It’s the first such ap­proval for any SMA drug avail­able to ad­min­is­ter at home in this in­fant pop­u­la­tion.

“The ap­proval of Evrys­di for pre-symp­to­matic ba­bies is par­tic­u­lar­ly im­por­tant, as ear­ly treat­ment of SMA, be­fore symp­toms start to arise, can help ba­bies to achieve mo­tor mile­stones,” Phase II prin­ci­pal in­ves­ti­ga­tor Richard Finkel said in a state­ment.

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