India's Hetero seeks emergency use nod for Merck's Covid-19 drug
Molnupiravir is an antiviral drug being developed by Merck & Co and Ridgeback Biotherapeutics for the treatment of non-hospitalised Covid-19 patients
India's Hetero Labs said on Friday it sought emergency use nod from the local regulator for Merck's Covid-19 drug molnupiravir, after interim data from a late-stage trial showed it helped reduce hospitalisations and speed up recovery in mild cases.
Molnupiravir is an antiviral drug being developed by Merck & Co and Ridgeback Biotherapeutics for the treatment of non-hospitalised Covid-19 patients.
Merck tapped several Indian generic drugmakers between March and April, including Cipla and Dr Reddy's Laboratories , to expand the drug's production and conduct trials, hastening its availability in India to address a second wave of infections.
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The partnerships gave these companies licence to make and supply molnupiravir to India and more than 100 low- and middle-income countries after approvals or emergency authorisations by local regulatory agencies, Merck said in late April.
Hetero said the late-stage trial of molnupiravir, conducted at Covid-19 dedicated hospital sites across India, looked at the drug's efficacy and safety in patients with mild Covid-19.
The data showed the antiviral drug resulted in statistically significant fewer hospital admissions, faster recovery time and early negative SARS-CoV-2 RT PCR results.
Coronavirus cases in India have declined from a devastating peak in April and May. However, health experts have said the country should brace for a third wave by October.
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.
