Lagevrio

Lagevrio was developed as a medicine for the treatment of adults with COVID-19 who did not require supplemental oxygen and who were at increased risk of developing severe COVID-19.

Lagevrio contains the active substance molnupiravir and was to be available as capsules to be taken by mouth.

The active substance in Lagevrio, molnupiravir, is an antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. It does this by increasing the number of alterations (mutations) in the virus’ genetic material (known as RNA) in a way that impairs the ability of SARS-CoV-2 to multiply.

The company submitted the results of one main study investigating Lagevrio in over 1,400 non-hospitalised, unvaccinated adults with at least one underlying condition putting them at risk of severe COVID-19. This study compared Lagevrio with placebo (a dummy treatment). The company also provided supportive data from other studies and real-world data on the use of molnupiravir in clinical practice.

Having evaluated the data provided by the company, EMA’s human medicines committee (CHMP) concluded that the clinical benefit of Lagevrio in the treatment of adults with COVID-19 who are not receiving supplemental oxygen and who are at increased risk of developing severe COVID-19 could not be demonstrated.

Based on the totality of data, it was not possible to conclude that Lagevrio can reduce the risk of hospitalisation or death or shorten the duration of illness or time to recovery in adults at risk of severe disease. Furthermore, it was not possible to identify a specific group of patients in whom a clinically relevant benefit of Lagevrio could be demonstrated.

Therefore, the Agency’s opinion was that the balance of benefits and risks of Lagevrio in the treatment of COVID-19 could not be established. Hence, the Agency recommended refusing marketing authorisation.

The company informed the Agency that there are no consequences for patients in clinical trials with molnupiravir. If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.