FDA Authorises Molnupiravir for Treatment of COVID-19 in Certain Adults

December 23, 2021

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe coronavirus disease 2019 (COVID-19), including hospitalisation or death, and for whom alternative COVID-19 treatment options authorised by the FDA are not accessible or clinically appropriate.

Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.

Molnupiravir is not authorised for use in patients aged younger than 18 years because molnupiravir may affect bone and cartilage growth.

Molnupiravir is not authorised for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalised due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalisation due to COVID-19.

Molnupiravir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

“Today’s authorisation provides an additional treatment option against COVID-19 in the form of a pill that can be taken orally,” said Patrizia Cavazzoni, MD, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “Molnupiravir is limited to situations where other FDA-authorised treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death. As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorisation, while continuing to generate additional data on their safety and effectiveness.” 

Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as 4 200-mg capsules taken every 12 hours for 5 days, for a total of 40 capsules. Molnupiravir is not authorised for use for longer than 5 consecutive days. 

The primary data supporting this EUA for molnupiravir are from MOVe-OUT, a randomised, double-blind, placebo-controlled clinical trial that included adults aged 18 years and older with a pre-specified chronic medical condition or who were at increased risk of SARS-CoV-2 infection for other reasons who had not received a COVID-19 vaccine. The primary endpoint was the percentage of people who were hospitalised or died due to any cause during 29 days of follow-up. Of the 709 people who received molnupiravir, 6.8% were hospitalised or died within this time period compared with 9.7% of the 699 people who received a placebo. Of the people who received molnupiravir 1 died during the follow-up period compared with 9 people who received placebo. Side effects observed in the trial included diarrhoea, nausea, and dizziness.

The safety and effectiveness of molnupiravir for the treatment of COVID-19 continue to be evaluated.

Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, molnupiravir is not recommended for use during pregnancy. Molnupiravir is only authorised to be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir would outweigh the risks for that individual patient and after the prescribing healthcare provider has communicated the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual. Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for 4 days after the final dose. Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least 3 months after the final dose.

Under the EUA, fact sheets that provide important information about using molnupiravir in the treatment of COVID-19 as authorised must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, and information about who is able to prescribe molnupiravir.

Reference: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

SOURCE: US Food and Drug Administration