The US regulator’s approval is based on the Phase 3 MOVe-OUT trial, which assessed molnupiravir 800 mg twice-daily in non-hospitalised adult patients who were unvaccinated against SARS-CoV-2
Merck Research Laboratories in South San Francisco, California. (Credit: Coolcaesar/ Wikipedia)
Merck and Ridgeback Biotherapeutics have received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for their investigational oral antiviral, molnupiravir, to treat Covid-19.
The drug, which is being jointly developed by Merck and Ridgeback Biotherapeutics, has been approved for emergency use in adults with positive results of direct SARS-CoV-2 viral testing.
It has been approved for adult patients who are at high risk for progression to severe Covid-19, including hospitalisation or death as well as for whom alternative Covid-19 treatment options approved by the US regulator are not available or clinically appropriate.
Merck’s drug is the second pill authorised by the US FDA for treating Covid-19 following Pfizer’s oral antiviral treatment, Paxlovid, for people aged 12 and older.
Merck President and CEO Robert Davis said: “The FDA emergency use authorisation of molnupiravir is an important milestone in the fight against Covid-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives.
“Because we recognised the promise of molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that molnupiravir, now authorised, can be available to patients here in the US and all around the world more quickly and more equitably than has ever been accomplished before.”
Molnupiravir has been authorised based on the Phase 3 MOVe-OUT trial, which assessed molnupiravir 800 mg twice-daily in non-hospitalised adult patients who were unvaccinated against SARS-CoV-2.
The FDA said that Merck’s drug is not authorised for use in patients aged below 18 years because molnupiravir may affect bone and cartilage growth. Furthermore, the pill is not recommended for use in patients who are pregnant, the US regulator added.
Merck Research Laboratories president Dr. Dean Y. Li said: “Based on the strong science behind molnupiravir – a single oral medicine that interrupts replication of the SARS-CoV-2 virus, with data demonstrating a significant reduction in the risk of hospitalizations and deaths – molnupiravir has the potential to become an important tool for healthcare professionals and appropriate patients.
“We are immensely grateful to all of our collaborators, including trial patients and clinical investigators, for their important contributions to this milestone.”
Merck expects that it will start shipping molnupiravir to AmerisourceBergen, which is the sole distributor of molnupiravir, within days.
To date, Merck agreed to supply approximately 3.1 million courses of molnupiravir to the US government, upon EUA from the FDA.