People in the know told ET that companies are expected to submit the data this month, after which the subject expert committee (SEC) will take it up again.
“The SEC was satisfied with the presentations made by the companies. There was only one requirement by the SEC that the companies should provide the subgroup data. This can easily be done in no time. Once that data is submitted the approval will come soon,” said a senior government official on the condition of anonymity.
The SEC, which advises the drug regulator on applications seeking approval for vaccines, new drugs and clinical trials, reviewed the applications of Dr Reddy’s along with other firms including Hetero Labs, Natco Pharma, Aurobindo Pharma, Optimus Pharma, Strides Pharma, MSN Pharma and BDR Pharmaceuticals.
Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate Covid-19 in adults and could potentially be the game-changer in fight against Covid-19.
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 discuss available data supporting the use of molnupiravir to treat mild-to-moderate Covid-19 infection in adults who have tested positive for the virus, and who are at high risk for progression to severe Covid-19.
In the phase-3 trial by Merck, molnupiravir reduced the risk of hospitalisation or death by 50% among newly sick people.