Sarepta's Elevidys secures US label expansion for DMD [Yahoo! Finance]
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
announced that it has scored a US label expansion for its DMD gene therapy Elevidys (delandistrogene moxeparvovec-rokl). As per the 20 June press release, the US Food and Drug Administration (FDA) has expanded Elevidys' label to include DMD patients with a confirmed mutation in the DMD gene who are at least four years of age. Based on its functional benefits, Elevidys was granted traditional approval for ambulatory patients and accelerated approval for the non-ambulatory population. However, according to the announcement, which drove Sarepta's shares up 36%, further progression on the approval track hinges on validated clinical benefits from a confirmatory study. When the therapy's durability came into question, particularly in a non-ambulatory population, Sarepta CEO Douglas Ingram said in an investor call held on 21 June, that Sarepta has a long-term post-approval commitment to evaluating the long-term durability of Elevidys in children over the next few decades. To this end,
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