Summit Therapeutics plc (NASDAQ: SMMT) was pleased to announce today that the US Food and Drug Administration (‘FDA’) granted Fast Track designation for ezutromid in the treatment of Duchenne Muscular Dystrophy (DMD). Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with the fatal muscle wasting disease DMD. Advantages of this designation include opportunities for frequent interactions with the FDA during all aspects of development, submission of a New Drug Application (‘NDA’) on a rolling basis, and eligibility for accelerated approval and priority review.
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About Summit Therapeutics
Summit Therapeutics is an international biopharmaceutical company focused on the discovery and development of novel medicines to treat the fatal muscle wasting disease Duchenne muscular dystrophy and infections caused by the bacteria C. difficile. Its goal is to become a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies.
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