MUMBAI: The US Food and Drug Administration on Thursday approved the world’s first oral antiviral, Paxlovid (nirmatrelvir and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adults who are at high risk for progression to severe Coronavirus, including hospitalization or death. Paxlovid, manufactured by US biggie Pfizer is the fourth drug—and first oral antiviral pill—approved by the USFDA to treat Covid-19 in adults. So far, Paxlovid was being sold under an emergency use authorization (EUA) in the US.
With the pandemic now in the endemic stage, oral treatments or pills are believed to be a potential game changer for mild to moderate infections.
A clutch of domestic companies including Cipla, Dr Reddy’s, Torrent, Hetero, Biocon, Emcure, Granules India, Glenmark and Sun Pharma signed agreements last year with Medicines Patent Pool for the manufacture of the generic drug substance and product. Overall, 35 generic manufacturers globally signed agreements with MPP to produce low-cost, generic versions of Pfizer’s oral COVID-19 treatment nirmatrelvir in combination with ritonavir, for supply in 95 low- and middle-income countries.
In India, Hetero announced ‘NIRMACOM’, the world’s first generic version of Paxlovid, had received WHO prequalification in December. The Hyderabad-based company also has EUA approval from the Drugs Controller General of India to manufacture and market the oral antiviral here. Now with the USFDA green light, the production of generics will get a further push, resulting in better availability and accessibility of the antiviral. Earlier this year, the demand for Paxlovid in China had shot up, resulting in a massive demand for Indian generic versions.
Under the Federal Food, Drug, and Cosmetic Act in the US, approval of a new drug requires, among other things, substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population
“While the pandemic has been challenging for all of us, we have made great progress mitigating the impact of COVID-19 on our lives,” said Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research. “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’’.
It may be noted that the antiviral is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of Coronavirus.