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Drugs with breakthrough status charm investors

Nature Biotechnology volume 31, pages 945–946 (2013)Cite this article

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The program's popularity is perhaps understandable. A new drug receives the designation if there is 'preliminary' clinical evidence indicating a substantial improvement over existing therapies for that life-threatening condition. For the chosen candidates, the promise from the US Food and Drug Administration (FDA) is “intensive guidance on efficient drug development” as early as phase 1, plus senior manager “commitment” and all the attractive features of FDA's existing 'fast track' program, such as rolling submissions, and expedited development and review. “We're led to believe that it's fast track on steroids,” sums up Patrick McEnany, chairman and CEO of Coral Gables, Florida–based Catalyst Pharmaceuticals, whose orphan treatment for Lambert-Eaton myasthenic syndrome (LEMS) received the breakthrough stamp in August 2013.

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    Melanie Senior

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Senior, M. Drugs with breakthrough status charm investors. Nat Biotechnol 31, 945–946 (2013). https://doi.org/10.1038/nbt1113-945

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