Molnupiravir
Indian drugs regulator seeks more info on Merck's Covid-19 pill
New Delhi/IBNS: Indian drug regulator CDSCO's expert panel has sought additional data from the companies seeking emergency use authorisation (EUA) for MSD's Covid-19 antiviral medication molnupiravir, media reports said.
The Subject Expert Committee (SEC), which advises Central Drugs Standard Control Organisation (CDSCO) on applications seeking new drugs, vaccines, clinical trials, has sought "additional data from the companies," reported ET.
Dr Reddy's along with other firms including Hetero Labs, Natco Pharma, Aurobindo Pharma, Optimus Pharma, Strides Pharma, MSN Pharma, and BDR Pharmaceuticals, have applied for the emergency approval of the medicine, reported ET.
Molnupiravir has been jointly developed by U.S.-based Merck and Ridgeback Biotherapeutics and is the first oral pill to get the UK drug regulator's approval even before U.S. regulatory clearance.
According to data from the clinical trials, it halves the chances of dying or hospitalisation in adults with mild-to-moderate Covid-19 and could potentially be the game changer in ending the pandemic.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalizations and deaths recently, Reuters had reported.
The drug is under review by the US Food and Drug Administration for emergency use authorisation.
The advisory committee of USFDA will be meeting on November 30 to study further data supporting the use of molnupiravir in adults tested positive for Covid-19, and at who are at high risk of progression to severe Covid-19, including hospitalization or death.
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