Alzheimer's Development Next For Acadia's Nuplazid, Despite Limited Initial Label
First product for Parkinson's psychosis looking at slow uptake.
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FDA is close to hitting a milestone in the short history of the Breakthrough Therapies designation: 50 indications approved under the abbreviated development and review pathway. In reflecting on the last three-plus years, agency officials say the quality of requests for Breakthrough are improving, and review divisions outside of the initial base of oncology are becoming more comfortable with granting designations.
FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.
Meeting with Morquio A patient and caregivers appears to have helped to assuage FDA concerns about clinical relevance of the Vimizim trial’s primary endpoint – and illustrates FDA’s openness to patient input even during specific reviews of new product applications.