Expert panel seeks additional info on Merck's Covid-19 drug

The Indian drug regulator's expert panel on Thursday sought additional data from the companies seeking emergency use authorisation (EUA) for MSD's Covid-19 antiviral medication molnupiravir.

The Subject Expert Committee (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. "The SEC will meet again as it sought additional data from the companies," sources told ET.

"We await official communication from the SEC on the outcome of the meeting," a spokesperson at Dr Reddy's told ET.

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 ending the pandemic.

The drug is under review by the US Food and Drug Administration for the emergency use authorisation. The advisory committee of USFDA will be meeting on November 30 to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate Covid-19 infection in adults who have tested positive for Covid-19, and who are at high risk for progression to severe Covid-19, including hospitalization or death.

In the Phase-3 trial by Merck, molnupiravir significantly reduced the risk of hospitalisation or death by around 50% among newly infected people, and also prevented 100% of deaths.

As reported by ET on Thursday, the Drug Controller General of India office had requested the firms to send a detailed summary of proposals and powerpoint presentations to SEC.

"The companies made their presentations before the SEC today, however, it was decided that a final decision will be taken in the next meeting, likely to happen next week," the same person said.