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After interim data from a late-stage trial showed it reduced cut hospitalizations and speed up recovery in mild instances, India’s Hetero Labs requested an emergency use OK from the local regulator for Merck’s COVID-19 medication molnupiravir on Friday.
Merck & Co. and Ridgeback Biotherapeutics are developing Molnupiravir, an antiviral medication for the treatment of COVID-19 patients who are not hospitalised.
Between March and April, Merck enlisted the help of several Indian generic drugmakers, notably Cipla and Dr. Reddy’s Laboratories, to ramp up production and undertake clinical trials, bringing the antibiotic to India in time to combat a new wave of infections.
Merck stated in late April that the partnerships provided these firms permission to manufacture and supply molnupiravir to India and more than 100 low- and middle-income countries after receiving permits or emergency authorizations from local regulatory regulators.
The late-stage trial of molnupiravir, Hetero stated, looked at the drug’s efficacy and safety in patients with mild COVID-19 in COVID-19 designated hospital locations across India.
The antiviral medicine resulted in statistically significant fewer hospital admissions, a faster recovery period, and early negative SARS-CoV-2 RT PCR results, according to the findings.
Coronavirus cases in India have decreased since reaching a dangerous high in April and May. Health experts, on the other hand, have warned that the country should prepare for a third wave by October.
Merck and partner Ridgeback are now testing Molnupiravir in a global late-stage research, with results expected in the fall of 2021.