Mumbai: The United States Food and Drug Administration (USFDA) granted approval to Paxlovid (nirmatrelvlr and ritonavir tablets), making it the first-ever oral antiviral medication authorized for the treatment of mild to moderate COVID-19 in adults who face a high likelihood of developing severe symptoms, such as hospitalization or death.
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Manufactured by the US pharma major Pfizer, Paxlovid is the world’s first antiviral pill and the fourth drug – licensed by the FDA to great corona virus in adults. So far, the drug was only used in the US, under Emergency Use Authorization (EUA).
Agreements signed to manufacture drug
Last year Medicines Patent Pool signed various agreements with a handful of domestic pharma companies such as Hetero, Cipla, Torrent, Emcure, Biocon, Glenmark, Sun Pharma, Granules India and Torrent regarding the production of the active ingredient of the medication.
A total of 35 generic drug manufacturers worldwide have entered into agreements with the Medicines Patent Pool (MPP) to manufacture affordable generic versions of Pfizer’s oral COVID-19 treatment, nirmatrelvir, in combination with ritonavir. These generic versions have been made available to 95 low and middle-income countries.
India’s vision towards the pill
Hetero, a company based in Hyderabad, India, recently revealed that “NIRMACOM”, the global pioneer in generic form of Paxlovid, was granted WHO pre-qualification in December. Furthermore, the Drugs Controller General of India has also granted the company Emergency Use Authorization (EUA) for the manufacturing and distribution of the oral antiviral within the country.
Now, with the approval from the USFDA, the production of generic versions will receive an additional boost, leading to improved availability and accessibility of the antiviral medication. Earlier this year, there was a significant surge in demand for Paxlovid in China, which consequently led to a high demand for Indian generic alternatives.
Paxlovid passes high evaluation process
In accordance with the Federal Food, Drug and Cosmetic Act in the United States, the approval process for a new medication necessitates the provision of substantial evidence showcasing its effectiveness and the demonstration of its safety for its intended use.
When evaluating a drug for approval, the FDA meticulously conducts a thorough assessment of its benefits and risks, adhering to rigorous scientific standards to ensure that the benefits of the product outweigh any potential risks for the intended population. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, stated, today’s approval signifies that Paxlovid has successfully met the FDA’s stringent criteria for both “safety and effectiveness.”