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Levo’s Carbetocin Faces Advisory Committee Hurdle Given FDA ‘Uncertainty’ About Its Effectiveness

Executive Summary

US FDA points to inconsistency in Phase II and Phase III study results, lack of additional substantiating studies and lack of robust statistical findings. Advisory committee is to vote on whether there is ‘substantial evidence’ that the nasal spray is effective in treatment of hyperphagia associated with Prader-Willi syndrome.

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