What We’re Reading: Alzheimer Drug Setback; Rural Health Care Investment; Monkeypox Drug Delivery

FDA Rejects Second Attempt to Expand Pimavanserin Use

After resubmitting its application a second time to expand the use of pimavanserin (Nuplazid) to treat Alzheimer disease–related psychosis, Acadia Pharmaceuticals was rebuffed by the FDA, reports Reuters. The FDA’s decision follows a 9-3 advisory panel vote in July—and a first denial in April 2021—that available data did not support the company’s claims of the antipsychotic drug’s effectiveness against hallucinations and delusions. The drug is currently approved for this indication in Parkinson disease.

Rural Health Care to Benefit From HHS/HRSA Investment

Approximately $60 million has been earmarked by HHS and the Health Resources and Service Administration (HRSA) to make inroads against rural and tribal health care inequity and to expand the workforce that services these individuals. According to an HHS statement, $46 million will come from the American Rescue Plan and support frontline workers in rural areas (eg, dental hygienists and community-based doulas), $10 million will be put toward medical residency programs in rural areas, and close to $4 million will fund awards to improve rural care delivery and quality and veterans’ access to care.

Siga to Deliver Monkeypox Drug in Deal With United States

Despite the intravenous (IV) form of Tpoxx from Siga Technologies only being approved by the FDA to treat smallpox, the US has agreed to pay $26 million for delivery of the antiviral drug by next year to treat the ongoing monkeypox outbreak, Reuters reports. Recently declared a public health emergency, the IV formulation will increase access to monkeypox treatment for those with oral symptoms from the rare disease, such as blisters and rashes. Guidance on Tpoxx’s expanded use as an investigational drug against monkeypox was recently provided by the CDC.