Molnupiravir has no safety concerns: MSD

NEW DELHI: MSD Pharmaceuticals, a wholly-owned subsidiary of Merck Sharp & Dohme and known as Merck & Co Inc, on Friday said it is confident in the clinical profile of molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death in case of Covid-19 patients in the Phase-iii clinical trials. Molnupiravir is being developed by MSD and Ridgeback Biotherapeutics for the treatment of mild to moderate Covid-19. “We provided relevant information as requested to help the DCGI determine the most appropriate use of molnupiravir in India.

“We are confident in the clinical profile of molnupiravir, which demonstrated a significant reduction in the risk of hospitalisation or death in our Phase-3 clinical trial with no observed safety concerns when compared to the placebo group,” MSD India said in a statement.

The company’s statement comes after ICMR Director-general Balram Bhargava said molnupiravir has major safety concerns and has not been included in the national protocol for the treatment of coronavirus. During a press briefing earlier this week, he said the World Health Organization and the UK have not included it for treatment.

Bhargava said the US has approved it based on only 1,433 patients in which three per cent reduction was observed in symptoms in patients with mild to moderate disease.

India’s drug regulator Central Drugs Standard Control Organisation on December 28 had approved Molnupiravir for the restricted use in emergency situations in patients with Covid.

“Molnupiravir will be available to appropriate patients with a doctor’s prescription,” MSD India stated. The restrictive emergency use has been granted to the eight generic manufacturers in India who have entered into voluntary licensing agreements with MSD, it added. “We provided relevant information as requested to help DCGI determine the most appropriate use of molnupiravir in India.”