Emmaus Needs US FDA Advisory Cmte. To Rescue Sickle Cell Disease Candidate
FDA reviewers disagree with Emmaus' extrapolation methods for holes in efficacy data for its L-glutamine ahead of May 24 Oncologic Drugs Advisory Committee meeting.
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Unmet Need Can Trump Anything At US FDA Panels, Even An Ill-Prepared Sponsor
Emmaus was unable to answer several questions about its product and was also missing several pieces of data, but FDA's Oncologic Drugs Advisory Committee didn't criticize the sponsor, and instead praised it for paying attention to the largely neglected sickle cell disease.
Sickle Cell Disease Treatment Gets Panel Nod Despite Efficacy Concerns
US FDA's Oncologic Drugs Advisory Committee votes 10-3 in favor of approving Emmaus' L- glutamine, touting its strong safety profile and the unmet clinical need in spite of agency's questions about efficacy results.