Lagevrio is the first oral, antiviral agent to be issued a conditional marketing authorisation by the UK’s MHRA for the treatment of COVID-19.
The MHRA has given approval to Lagevrio (molnupiravir) for patients with mild to moderate symptoms of COVID-19, to reduce their risk of hospitalisation and death. Although the results of the Phase III clinical trial, MOVe-OUT, are yet to be published, the manufacturer, Merck and Ridgeback, posted interim results in a press release at the beginning of October 2021.
The interim analysis showed that among patients taking lagevrio, 7.3% were hospitalised compared to 14.1% assigned to placebo (risk difference = 6.8, p = 0.0012). In addition, through to day 29 after randomisation, there were no reported deaths among those taking lagevrio compared with 8 in the placebo arm.
The MHRA says that it has undertaken a “rigorous review of its safety, quality and effectiveness” adding that “Lagevrio is most effective when taken during the early stages of infection” hence the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset.
According to the Summary of Product Characteristics of the drug, Lagevrio is indicated “for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe illness.” The recommended dose is four 200mg capsules taken every 12 hours for 5 days although the efficacy if taken over a longer period of time is yet to be established.
While approved for use in the UK, both the the FDA and the EMA are currently undertaking a review of the data on Lagevrio and will no doubt make an announcement in due course.
Commenting on the MHRA approval, its chief executive Dr June Crown said “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.”