San­thera’s va­morolone bags FDA ap­proval for Duchenne af­ter long jour­ney

Swiss biotech San­thera has at last won FDA ap­proval for its steroidal drug va­morolone to treat boys and men with Duchenne mus­cu­lar dy­s­tro­phy, with a launch an­tic­i­pat­ed ear­ly next year.

Va­morolone, brand­ed as Agam­ree, is now in­di­cat­ed for DMD pa­tients aged 2 and old­er. The drug is de­signed to over­come is­sues as­so­ci­at­ed with stan­dard-of-care cor­ti­cos­teroids, in­clud­ing se­vere side ef­fects that can force pa­tients to drop down to a less ef­fi­ca­cious dose.

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