In short
Molnupiravir (Lagevrio) is no longer available in Belgium
The Committee for Medicinal Products for Human Use (CHMP) of the EMA did not give a positive opinion for market authorization on 23/02/2023. The EMA concluded after reviewing the data provided by the pharmaceutical company that the clinical benefit of Lagevrio in the treatment of adults with COVID-19 who are not receiving supplemental oxygen and are at increased risk of developing severe COVID-19 could not be demonstrated.
Molnupiravir (Lagevrio) is a new oral medicine that inhibits the replication of the coronavirus. A study showed that the product reduces hospitalisation and mortality in people with COVID-19 symptoms and an increased risk of developing a severe form of COVID-19. At the end of December 2021, the Belgian Government purchased 10,000 treatments of the medicine molnupiravir on the advice of the federal Task Force COVID Therapeutics. Although at that time the product had not yet received official approval from the European Medicines Agency (EMA), due to the pandemic context the use was already authorised by the European and Belgian health authorities (Moniteur belge, Numac: 2022030887). The Task Force recommended that the product be used in nursing homes with outbreaks of COVID-19 because of the vulnerability of the residents. Treatment should be started within 5 days of the onset of symptoms and last for 5 days. The regional health authorities and Sciensano were asked to collect data on the use of molnupiravir in nursing homes.
Project description
Molnupiravir (Lagevrio) is a new oral antiviral medicine that reduces the replication of SARS-CoV-2 in the body. The product inhibits the multiplication of the virus by introducing errors into the newly created viral RNA.
On 19 November 2021, the Committee for Human Medicinal Products of EMA formulated an opinion on the use of molnupiravir. This was based on an interim analysis of a phase 3 clinical trial for the treatment of adults with COVID-19 at increased risk of developing a severe form of COVID-19. The interim results (N=775) showed an:
- absolute risk reduction of 6.8%
- relative risk reduction of 49%
for hospitalisation and mortality in the molnupiravir-treated group compared to the placebo arm.
On 26 November 2021, updated results of the phase 3 study were available, including data from all participating patients (N=1433). The absolute and relative risk reductions were revised downwards to 3% and 31%, respectively. The EMA advice on the use of molnupiravir was not changed. The product was well tolerated and no serious side effects occurred. The study has since been published.
Treatment should be started within 5 days of the onset of symptoms. Treatment consists of administration of 800 milligrams of molnupiravir twice daily for 5 days (4 capsules of 200 mg twice daily).
At the end of December 2021, the Belgian Goverment purchased 10,000 treatments of molnupiravir on the advice of the federal Task Force COVID Therapeutics. Although at that time the medicine had not yet received official approval from the European Medicines Agency (EMA), due to the pandemic context the use was already authorised by the European and Belgian health authorities. The European market authorisation procedure is still ongoing in early 2022.
According to the federal Task Force COVID Therapeutics, the deployment of molnupiravir in nursing homes and hospital wards with outbreaks of COVID-19 can be beneficial, as it concerns infections in high-risk patients with a rapid confirmed diagnosis. In addition, easy access to the medicine can be guaranteed. Therefore, in January 2022 a protocol was established that describes the controlled and documented use of molnupiravir for the early treatment of COVID-19 in nursing home residents during an outbreak. Sciensano was asked to participate in the development of the protocol (available in French and Dutch). You can find the data collection forms at the bottom of this page.
Patients can be treated if the:
- diagnosis of COVID-19 infection was made on the basis of a molecular (RT-PCR) or antigen test (rapid Ag test or laboratory antigen test)
- infection is part of a COVID-19 outbreak in a nursing home
- resident has an increased risk of developing a severe form of COVID-19
- resident has been experiencing COVID-19 symptoms for maximum 5 days.
Data collection
The regional health authorities and Sciensano were asked to collect data on the use of molnupiravir in residential care centres (data collection forms are available in Dutch and French).
You can download the Excel forms for the data collection here:
Sciensano's project investigator(s):
Service(s) working on this project
Partners
