Drugs

FDA Tells Acadia that Nuplazid sNDA has Deficiencies

FDA has told Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and delusions associated with dementia-related psychosis, has found deficiencies that preclude labeling and post-marketing requirements/commitments discussions at this time. The agency stated that its communication about the deficiencies does not reflect a final decision on the information under review, Acadia says.

FDA accepted the supplemental NDA for review 7/2020 and assigned a standard review with a user fee review action date of 4/2/2021. Acadia said at the time that the submission was based on data from the pivotal Phase 3 HARMONY study, which met its primary endpoint — demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo. It also included a large safety database from completed and ongoing studies representing over 1,500 patients with neurodegenerative disease. Nuplazid was approved in 2016 for hallucinations and delusions associated with Parkinson’s disease psychosis.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome