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 The company has withdrawn its EU filing for the product following its announcement that it was halting development.
Santhera Pharmaceuticals has formally withdrawn its marketing authorization application (MAA) for idebenone following its recent decision to end the global program under which it was developing the drug as a potential treatment for the rare disease of Duchenne muscular dystrophy (DMD).
The Swiss company made the decision to halt the program after an interim futility analysis indicated that idebenone would be...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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