Sun Pharmaceutical Industries said it was gearing up to introduce Merck Sharpe Dohme (MSD) and Ridgeback’s molnupiravir under the brand name Molxvir in India. The Drugs Controller General of India is reviewing clinical data of molnupiravir for treatment of COVID-19 in adults in India, the drugmaker said.
Earlier this year, Sun Pharma had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply molnupiravir in India and to over 100 low and middle-income countries (LMICs). Molnupiravir is the first oral antiviral approved by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID -19 in adults.
It is under review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).
Kirti Ganorkar, CEO of India Business, Sun Pharma said, “The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the U.K. regulator is a positive step.”
“In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we are gearing up to make Molxvir available to patients and healthcare providers across India at an economical price post approval by DCGI,” he said.
Molxvir will be manufactured at one of Sun’s Indian plants and the company said it had enough capacity to meet demand.
In the phase-3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalisation or death by approximately 50% in a planned interim analysis of the MOVe-OUT trial in at risk, non- hospitalised adult patients with mild-to-moderate COVID-19, it said.
Published - November 11, 2021 10:54 pm IST
