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 for the emergency use authorisation.
“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.
Molxvir will be manufactured at one of the company’s plants in India and it has enough capacity to meet the demand, he added.
In the Phase-III trial by Merck, Molnupiravir significantly reduced the risk of hospitalisation or death by around 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 (around 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta and Mu.
The United Kingdom last week became the first country to authorize molnupiravir. In a clinical trial, the antiviral was shown to cut Covid hospitalizations by 50 per cent among newly infected people, and also prevented 100 per cent of deaths.
Molnupiravir, as a small molecule, has the advantage of not requiring cold storage like messenger RNA vaccines.
Pfizer has also announced promising results for its oral Covid pill, paxlovid, and expects to produce 180,000 courses this year, and at least 50 million next year.
