Shares of Acadia Pharmaceuticals (Nasdaq: ACAD) were down 7.8% at $14.40 pre-market today, after the US drugmaker said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
The decision comes after the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) in June voted 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population.
It is the second time trying for Acadia to expand the indication for pimavanserin, which in April 2021 received a Complete Response Letter (CRL) from the FDA in relation to its application for dementia-related psychosis.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze