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Re: IanFromSI post# 3128

Wednesday, 06/15/2022 12:50:42 PM

Wednesday, June 15, 2022 12:50:42 PM

Post# of 3158
FDA Says 'No Key Safety Issue' on ACADIA Pharmaceuticals' Resubmitted Application for Pimavanserin
2022-06-15 12:43:56 PM ET (MT Newswires)



12:43 PM EDT, 06/15/2022 (MT Newswires) -- The US Food and Drug Administration said in a briefing document that it has "no key safety issue" to raise before the psychopharmacologic drugs advisory committee regarding ACADIA Pharmaceuticals' (ACAD) resubmitted supplemental new drug application for pimavanserin.

Pimavanserin is an experimental psychosis drug for patients with Alzheimer's disease.

In a clinical trial with 392 participants, the most common adverse reactions include peripheral edema and confusional state, according to the FDA.

The regulator had previously set a target action date of Aug. 4 for the supplemental NDA.

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