SEC to meet today to take up applications seeking nod for MSD’s COVID pill

India’s drug regulator’s subject expert committee (SEC) will meet today to review petitions from more than a dozen drugmakers seeking rapid approval of Merck Sharpe Dohme’s COVID-19 antiviral medicine molnupiravir. According to sources close to the situation, the SEC is anticipated to reach a decision on molnupiravir’s approval recommendation before the end of the day. Dr Reddy’s Laboratories, which sought for permission in a partnership with five other businesses, as well as MSD, Hetero Labs, Natco Pharma, Aurobindo Pharma, Optimus Pharma, Strides Pharma, MSN Pharma, and BDR Pharmaceuticals, will be considered.

The Drug Controller General of India (DCGI) has requested that the drugmakers submit the SEC a full explanation of their plans as well as PowerPoint presentations. The meeting will be held through video conference between the hours of 12 p.m. and 6 p.m.

Molnupiravir was created in collaboration with Merck Sharpe Dohme and Ridgeback Biotherapeutics.

Yesterday, Pfizer applied for approval from the US Food and Drug Administration for its Paxlovid pill, meant to treat patients who are sick with COVID. Fellow drugmaker Merck asked the FDA to grant emergency authorization for its COVID pill, called molnupiravir, last month.

If the agency approves either request, treatments in the US could be available before the year’s end — joining Britain, which approved molnupiravir on November 4, becoming the world’s first country to do so. The FDA’s Antimicrobial Drugs Advisory Committee has not released a timeline for reviewing Pfizer’s data yet, but plans to meet on November 30 to discuss Merck’s data. Once approved, the Centers for Disease Control and Prevention would then need to craft nationwide guidelines for using the drugs.
MB Bureau