Lessons Learned: Santhera Will Refile Raxone For DMD In EU Next Year
Santhera plans to refile Raxone for the new indication of Duchenne muscular dystrophy with the European Medicines Agency in 2019 after the CHMP upheld its earlier negative opinion; the company's US regulatory strategy remains unchanged.
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Swiss company Santhera's lengthy and problem-laden journey to repurpose its already marketed idebenone for use in Duchenne Muscular Dystrophy has ended in failure. The company has withdrawn its EU filing for the product following its announcement that it was halting development.
Santhera needs more time to address concerns regarding its current EU application for idebenone in the DMD setting but the Swiss biotech is keeping its sights on a broader indication.
The Swiss company believes it has collected sufficient new data on Raxone for Duchenne muscular dystrophy to convince regulators and hopes to file for that indication on both sides of the Atlantic by the end of the first quarter of 2019.