Hetero seeks DCGI nod for EUA of Molnupiravir
The interim data of the Phase-3 trial showed there were fewer hospital admissions in Molnupiravir group compared to standard of care alone over 14 days of observation
image for illustrative purpose
Hyderabad: Pharma player Hetero, on Friday announced the interim clinical results from Phase III Clinical trials of Molnupiravir in mild Covid-19 patients conducted across multiple Covid-19 dedicated hospital sites in India.
The drug maker has sought emergency use approval (EUA) from the Drug Regulator Controller of India (DCGI) for experimental antiviral drug Molnupiravir. The interim data of the Phase-3 trial showed there were fewer hospital admissions in Molnupiravir group compared to standard of care alone over 14 days of observation.
Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog,
being developed globally by US-based Merck Sharp & Dohme Corporation that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of Covid-19 with demonstrated activity against SARSCoV-2 in human airway epithelial cell cultures and potential to completely eliminate SARS CoV-2 from the body within 5 days.
In April the drug maker had entered into a non-exclusive licensing agreement with MSD to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries.
The pharma firm said all adverse events were non-serious, mild in severity, and none led to drug discontinuation. Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely, it said. Hetero is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by CDSCO.
