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Nov, 7 2021
Britain has become the first country in the world to approve Lagevrio (molnupiravir). The drug is touted as a potential game changer for the management of COVID-19 patients. The Medicines and Healthcare products Regulatory Agency (MHRA), the drug regulatory body of Britain has found it to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease.
Lagevrio (molnupiravir) has been jointly developed by Ridgeback Biotherapeutics and U.S. based Merck Sharp & Dohme (MSD), in an effort to fight against the pandemic. Lagevrio works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease. Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset.
MHRA in press statement has stated that the approval process followed a rigorous review of its safety, quality and effectiveness by themselves and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the first oral antiviral for the treatment of COVID-19 to be approved. Molnupiravir has been authorized for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.
“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage. With no compromises on quality, safety, and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data,” said Dr June Raine, MHRA chief executive, in a press release.
This development has paved the way for its approval in many countries including USA, EU, India etc. Many firms have already lined up their NDA in India which are awaiting DCGI’s nod.
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