Hyderabad-based Hetero Labs on Friday announced that it has sought emergency use approval from the drug regulator for Merck’s COVID-19 drug molnupiravir, according to a report by Reuters. According to the report, an interim data from a late-stage trial of the drug revealed that it helped reduce hospitalisations and speed up recovery in mild COVID cases.
Molnupiravir, an antiviral drug, is being developed by Merck & Co and Ridgeback Biotherapeutics for treating non-hospitalised COVID-19 patients.
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US-based Merck talked to several Indian generic pharma giants between March and April, including Cipla and Dr Reddy’s Laboratories, to expand the drug’s production and conduct trials in India to address a second wave of infections.
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In late April, the US-based pharma said that the partnerships gave these companies licence to make and supply the drug to India and other 100 low- and middle-income countries. In India, the late-stage trial of molnupiravir, were conducted at COVID-19 dedicated hospital sites. The aim was to look at the drug’s efficacy and safety in patients with mild COVID-19.
According to the data, the drug statistically reduced hospital admissions, increased recovery time and gave early negative SARS-CoV-2 RT PCR results.
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In India, the coronavirus cases are declining from a devastating peak in April and May. However, health experts have said the country should brace for a third wave by October. India currently has over 4 lakh active coronavirus cases and over 36 crore people have been vaccinated against the deadly virus since January 2021.
Molnupiravir is currently being tested in a global late-stage study by Merck and partner Ridgeback, with the trial data expected in the fall of 2021.