FDA approves Santhera's DMD drug Agamree

The US Food and Drug Administration (FDA) yesterday approved the new drug application (NDA) for Agamree (vamorolone) as a treatment of patients aged two years or more with Duchenne muscular dystrophy (DMD), that was submitted by Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN), whose shares were down 4.8% at 12.66 francs in mid-morning trading.

The FDA approved Agamree on the basis of the pivotal Phase IIb VISION-DMD study as supplemented with safety information collected from three open-label studies, including extension studies. In these trials, Agamree was administered at doses ranging from 2 to 6mg/kg/day, extending for a period of up to 48 months.