Hyderabad – based drug maker Hetero on Friday sought emergency use approval from the Drug Regulator Controller of India (DCGI) for experimental antiviral drug Molnupiravir, saying the Phase-3 clinical trial of the oral drug have shown early recovery and reduced hospitalizations among Covid patients with mile symptoms.
Molnupiravir is an investigational, orally administered form of drug being developed globally by US-based Merck Sharp and Dohme Corporation, that inhibits the replication of multiple RNA viruses including SARS-COV2, the causative agent of Covid 19.
In April, 2021, Hetero had tied up with MSD to manufacture and supply Molnupiravir in India and over 100 low and middle and low-income countries.
Hetero said the late-stage trial of Molnupiravir, conducted at Covid 19 dedicated hospitals sites across India, looked at the drug's efficacy and safety in patients with mile COVID 19.
Patients in the clinical trial were randomized to receive either Hetero's Molnupiravir capsules 800 mg every 12 hours(twice daily) for 5 days along with the standard of care as per the Indian Council of Medical Research guidelines.
“Phase 3 trail demonstrates statistically significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir treatment in mind Covid-19 patients compared to standard of care alone”, Hetero said.
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.