July 6 Quick Takes: FDA authorizes pharmacists to prescribe Paxlovid

FDA has revised the EUA for Paxlovid nirmatrelvir/ritonavir from Pfizer Inc. (NYSE:PFE) to allow it to be prescribed by pharmacists, with certain limitations — an important change that could allow patients to receive it soon after testing positive for COVID-19 at a pharmacy. The agency said patients should demonstrate their eligibility for Paxlovid by showing the pharmacist a copy of their health records, including lab work, and a list of all medications they are taking. Pharmacists unable to assess patient renal and hepatic function and drug interactions should refer patients to a physician, advanced practice registered nurse, or physician assistant, the agency said.

Lecanemab (BAN2401) from Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB) is now under FDA review under the accelerated approval pathway and priority review to treat early Alzheimer's disease with confirmed presence of amyloid pathology in the brain. The PDUFA date for the anti-amyloid β protofibril antibody is Jan. 6, 2023. Primary endpoint data from the Clarity AD Phase III trial, which FDA has said can serve as the confirmatory study for the therapy, are due in the fall...