UK approval next for Santhera’s Agamree in DMD

Swiss specialty pharma Santhera Pharmaceuticals (SIX: SANN) has announced that Agamree (vamorolone) has been approved in the UK for Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), adopting the view of the European Medicines Agency (EMA), acknowledged clinically important safety benefits of Agamree with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy.

"Initial European launch will be in Germany in Q1"Steroids, the standard medication for children with DMD, can keep patients independently mobile for longer. But they come with potentially harmful side effects.