Sun Pharmaceutical Industries disclosed in a statement issued on November 11 that is preparing to introduce Merck Sharp Dohme (MSD) and Ridgeback’s molnupiravir under the brand name Molxvir in India.
The Drugs Controller General of India (DCGI) is reviewing the clinical data of molnupiravir; the world’s first anti-COVID oral antiviral approved by the United Kingdom, for the treatment of COVID-19 in adults in India.
The medicine 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 for the emergency use authorisation.
Earlier in 2021, 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.
“The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the UK 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,” Sun Pharma India Business CEO Kirti Ganorkar said in a statement.
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, non-hospitalised 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 and Delta.