12 November 2021 | News
DCGI is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults in India
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Sun Pharmaceutical Industries is 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 (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults in India.
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. It is under review by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).
In the Phase 3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalisation or death by approximately 50 per cent in a planned interim analysis of the MOVE-OUT trial in at-risk, nonhospitalised adult patients with mild-to-moderate COVID-19.
Additionally, based on the participants with available viral sequencing data (approximately 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta, and Mu Molxvir is a registered trademark of Sun Pharma.