Santhera plans for US and EU approval filing of Raxone for DMD

Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) has reported new data and updates on regulatory filings for Raxone (idebenone) in Duchenne muscular dystrophy (DMD)

These and other supporting analyses previously discussed with regulatory authorities will be included in the regulatory filings in the USA and European Union) expected for the first quarter of 2016. In order to expand the DMD population that is the subject of these initial filings, the company also prepares to conduct a new trial in DMD patients using glucocorticoid steroids.

Thomas Meier, chief executive of Santhera, commented: "Together with the recently completed patient and caregiver survey prepared by PPMD, which underlined the importance of treating pulmonary complications in patients with DMD, we have now all data we wanted to include in our regulatory filing dossiers according to our previous discussions with regulators. The expected shorter review timelines due to the fast track status allowing for priority review in the USA and a filing as a Type II variation of the existing marketing authorization in the EU should lead to regulatory decisions next year. The new study we plan to start soon addresses a clear medical need for the treatment of respiratory function decline also in patients using glucocorticoid steroids and follows requests by physicians and the DMD community. If successful, we will seek to extend the label accordingly to include this substantial group of DMD patients."