Acadia flies high on quicker path to US approval
This article was originally published in Scrip
Executive Summary
Magic words from theUS FDA – no second Phase III trial required – sent shares of Acadia Pharmaceuticals flying upwards 75% on 11 April, with regulators telling the firm data from its pivotal Phase III 020 study of pimavanserin, together with supportive data from other trials, are sufficient to support a submission of a new drug application (NDA) for the experimental drug as a treatment for Parkinson's disease psychosis (PDP).