With Duchenne Filing Due, Santhera Moves Vamorolone Into Becker Muscular Dystrophy
Rare Disease Trial Receiving FDA Funding
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.
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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.
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 rare diseases firm Santhera has signed a licensing deal for its Duchenne muscular dystrophy drug vamorolone, which could be launched in both the US and the EU by the end of the year, paying off short-term debt and cleaning up the balance sheet.