India’s Hetero seeks emergency use nod for Merck’s COVID-19 drug
BENGALURU, July 9 (Reuters) – 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 (MRK.N) and Ridgeback Biotherapeutics for the treatment of non-hospitalised COVID-19 patients.
Merck tapped several Indian generic drugmakers between March and April, including Cipla (CIPL.NS) and Dr Reddy’s Laboratories (REDY.NS), to expand the drug’s production and conduct trials, hastening its availability in India to address a second wave of infections.
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.
Reporting by Vishwadha Chander in Bengaluru; Editing by Subhranshu Sahu
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