Advisory panel recommends full FDA approval for COVID-19 medication Paxlovid
Source: UPI
Health News March 16, 2023 / 6:58 PM
March 16 (UPI) -- A panel of independent advisers Thursday recommended the U.S. Food and Drug Administration give full approval to COVID-19 treatment Paxlovid, which is produced by Pfizer.
The Antimicrobial Drugs Advisory Committee voted 16 to 1 in favor of the recommendation, following Thursday's meeting. The committee said it found the benefits of the co-packaged, two-drug oral medication outweighed the risks.
Up until now, the investigational medicine had only been authorized for emergency use by the FDA, which was granted in 2021. A final decision from the FDA is expected in May. The agency typically follows the recommendations of its independent advisory panels, but is not required to do so.
A report released ahead of Thursday's hearing found the drug to be safe and effective when used to treat adults at risk of severe COVID-19 symptoms, including hospitalization or death. Over 11 million people across the globe have taken the New York-based biopharmaceutical company's combination of nirmatrelvir and ritonavir so fa
Read more: https://www.upi.com/Health_News/2023/03/16/panel-recommends-fda-approva-pfizer-paxlovid/9691679005057/
Thought I heard about a vote but wasn't sure for which product. Paxlovid is currently operating under an EUA (Emergency Use Authoration) and this is the next step before their receiving a full nod.
