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 Helped Boehringer's Ofev Win Favorable Advisory Cmte. Vote For New Indication – Or Did It?
US FDA's Arthritis Advisory Committee members who qualified their votes in recommending approval for Ofev to treat SSc-ILD could complicate the agency’s decision.
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.
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.