The U.S. Food and Drug Administration (FDA) expanded Pfizer's
The action effectively removes prescribing limits on the drug that were initially only giving to health care providers and COVID-19 Test-to-Treat sites ran by the U.S Department of Health and Human Services (HHS).
"The FDA recognizes the important role pharmacists have played and continue to play in combating the pandemic," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement Wednesday. "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."
Paxlovid is authorized to treat mild-to-moderate COVID infections in patients who are at high risk of developing severe disease. The drug is given in a five day course containing the antiviral nirmatrelvir and a common HIV drug ritonavir, which helps the antiviral work longer in the patient's metabolism. The drug is authorized for patients aged 12-years-old and up.
Under the new authorization, patients are eligible for the medications if they are at high risk of severe infection, hospitalization and death and have a positive at-home rapid antigen test or a positive PCR test, the FDA said. It is not required for patients to confirm a positive at-home test with a PCR test, the agency added.
The agency noted that patients who test positive to COVID should still consider contacting their healthcare provider before consulting a pharmacist for a prescription. A patient will still need to provide health records less than 12 months old, including the more recent blood work results, to pharmacists to review for kidney or liver problems. Patients should also provide a list of all medications they are currently taking before starting Paxlovid.
Separately, the FDA did not expand Merck's
"The FDA has determined that Lagevrio should only be prescribed by traditional prescribers," the FDA wrote to Fierce Pharma in an email. "This determination is based on several factors, including the drug's side effect profiles and the need for provider-patient consultation."
