Levo’s Carbetocin Faces Advisory Committee Hurdle Given FDA ‘Uncertainty’ About Its Effectiveness
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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Patient representative was lone ‘yes’ vote, and even she acknowledged using a broad interpretation of ‘substantial evidence.’ The only route forward for Levo may be a new trial, though expanded access could be an option in the near term.
The US FDA has asked Soleno to conduct another Phase III Study evaluating its chief asset in Prader-Willi syndrome patients prior to any NDA submission, rattling investors and clouding the company’s prospects.
Attempts at developing an effective therapy for PWS, and the abnormal desire for food associated with the rare disorder, have been fruitless but Levo Therapeutics' enthusiasm for LV-101 remains high, despite a Phase III setback.