Drugs

Acadia Gets 2nd Complete Response on Alzheimer's Drug

FDA has issued Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The letter recommended the company conduct an additional trial in ADP. “While the FDA stated that Study 019 demonstrated a statistically significant treatment effect on its primary endpoint, they concluded that there are limitations in the interpretability of the 019 results,” the company says. “The FDA also stated that the positive treatment effect of pimavanserin on dementia-related psychosis in Study 045 (HARMONY) appeared to be driven by the robustly positive results in the Parkinson’s disease dementia subgroup, a condition they stated is subsumed within the currently approved Nuplazid Parkinson’s disease psychosis (PDP) indication. Up to 50% of PDP patients have dementia.”

In June, FDA’s Psychopharmacologic Drugs Advisory Committee voted 9-3 to not recommend approval of the sNDA. The panel members did not find the company’s data sufficient to approve the drug in this patient population, with some recommending a randomized study in Alzheimer’s patients. Acadia had studied the drug in Parkinson’s and Alzheimer’s patients with psychosis, but some panel members suggested the Parkinson’s patients may have skewed results.

FDA 4/2021 issued Acadia a complete response letter (see story) on an earlier sNDA, indicating that the submission could not be approved in its then-present form. At the time, the agency cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less-common dementia subtypes as lack of substantial evidence of effectiveness to support approval, according to the company.

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