FDA approves Italfarmaco’s drug Duvyzat for Duchenne muscular dystrophy

The FDA ap­proved the first non­s­teroidal drug to treat all ge­net­ic vari­ants of Duchenne mus­cu­lar dy­s­tro­phy, clear­ing drug­mak­er Ital­far­ma­co’s oral treat­ment for pa­tients age 6 and old­er.

The drug, givi­no­s­tat, will be sold as Du­vyzat, the FDA said in a press re­lease an­nounc­ing the ap­proval. It’s dif­fer­ent than ge­net­ic med­i­cines ap­proved for Duchenne, such as ex­on skip­ping drugs or gene ther­a­py, which re­quire pa­tients to have cer­tain mu­ta­tions.

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