Posted by Michael Wonder on 21 Jun 2016
Santhera’s marketing authorization application for Raxone in Duchenne muscular dystrophy validated by the European Medicines Agency
21 June 2016 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorization application for Raxone (idebenone) for Duchenne muscular dystrophy in patients with respiratory function decline who are not taking concomitant glucocorticoids.
Validation confirms that the submission, which was filed as Type II variation of the Company’s existing marketing authorization for Raxone, is complete and that the review process by the CHMP has begun. Santhera expects an opinion from the CHMP in the first quarter of 2017.
Raxone was approved in September 2015 for the treatment of visual impairment in adolescent and adult patients with Leber's hereditary optic neuropathy in all EU member states, Norway, Iceland and Liechtenstein.
For more details, go to: http://santhera.com/docs/default-source/2016/2016-06-21-ema-validation-e-web.pdf?sfvrsn=4
