Santhera Sets Out Launch Strategy For CHMP-Backed Duchenne Drug
In a major boost for Santhera and Duchenne muscular dystrophy patients, EU regulators have backed the firm’s Agamree for children aged four years and older and a launch in Germany is scheduled for January.
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The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing authorization for a number of new products.
The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.
Santhera is bouncing back after a Duchenne drug failure two years ago with idebenone, and is looking to gain approval of vamorolone in this indication as well as the much rarer Becker muscular dystrophy.