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USFDA approves first oral antiviral drug Paxlovid for COVID-19

According to the agency, the antiviral pill will be used for treating adult patients with mild to moderate Covid-19 who are at risk for severe disease.

• By Newsdesk
• The US
• May 26, 2023

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The US Food and Drug Administration on Thursday gave approval to Pfizer's Paxlovid for the treatment of Covid-19.

The Paxlovid (nirmatrelvir-ritonavir) tablets become the world’s oral first antiviral pill to treat Covid-19, as approved by the US FDA. The pill is the fourth drug in line, manufactured by the US Pharma giant Pfizer, to treat the Covid infection in adults.

According to the agency, the antiviral pill will be used for treating adult patients with mild to moderate Covid-19 who are at risk for severe disease. “It will help ward off hospitalization and death in high-risk patients”, the agency said.

"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

The US FDA approval of the antiviral has been largely anticipated since March. However, there were some concerns regarding the rebound cases and a host of drug-drug interactions, due to which the drug had to have a boxed warning on its label and fact sheet for healthcare providers.

"Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring," according to the FDA. "Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed,” it said.

According to the instructions, the antiviral is to be taken within five days of the beginning of the covid-related symptoms. Post the approval; the pharmacists will be able to prescribe the drug directly to patients.

Interestingly, Nirmatrelvir-ritonavir was a critical component of US President Biden's test-to-treat strategy during the covid-19 pandemic.