The company said the Drugs Controller General of India (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults.
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 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 USFDA for Emergency Use Authorisation (EUA).
“The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the UK regulator is a positive step,” said Kirti Ganorkar, CEO of India Business, Sun Pharma.
“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,” Ganorkar said.
Sun Pharma said the antiviral drug will be manufactured at one of its plants in India and it has enough capacity to meet the demand.
In the Phase 3 trial by MSD, molnupiravir significantly reduced the risk of hospitalization or death by approximately 50% in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. Additionally, based on the participants with available viral sequencing data approximately 40% of participants who received molnupiravir demonstrated consistent efficacy across viral variants like Delta, Gamma and Mu.
