NATIONWIDE — The U.S. Food and Drug Administration (FDA) has announced the authorization of an oral antiviral COVID-19 treatment for certain adults.
The drug, Merck and Ridgeback Biotherapeutics’ Molnupiravir, has received an emergency use authorization (EUA) as a treatment for some adults with mild to moderate cases of the coronavirus disease and have received a positive result from direct SARS-CoV-2 viral testing. Adults who may be authorized for this treatment are those considered at high risk for progression to severe COVID-19 (which may include hospitalization or even death), and for whom traditional alternative COVID-19 treatment options authorized by the FDA are either not accessible or considered not clinically appropriate for the case.
“[This] authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other FDA-authorized 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,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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 authorization, while continuing to generate additional data on their safety and effectiveness.”
According to the FDA, Molnupiravir works by introducing errors into the SARS-CoV-2 virus’ genetic code, which will prevent it from further replicating. It is administered in four 200 milligram capsules and taken orally every 12 hours for five days, for a total of 40 capsules. It is not authorized to be taken longer than five days.
Both FDA and Merck note that it is important that treatment using Molnupiravir should begin as soon as possible following a positive COVID-19 diagnosis.
Molnupiravir is not authorized for patients who are younger than 18 years of age as it may impact bone and cartilage growth. It is also not authorized for pre- or post-exposure prevention of COVID-19 nor is it authorized as the initiation of treatment for hospitalized patients as the benefit of treatment has not yet been observed in this population. Additionally, Molnupiravir cannot be used by patients who are pregnant as it may cause fetal harm.
Additionally, this medication should not be considered as a substitute for individuals who are eligible for the COVID-19 vaccine and its booster. The Pfizer-BioNTech vaccine is currently the only one that has been fully approved by the FDA while the Moderna and Johnson & Johnson vaccines remain under EUAs. To learn more about vaccination options or to schedule an appointment to receive either the initial series of vaccines or a booster in the Commonwealth of Virginia, please visit the website for Vaccinate Virginia.
An EUA is not the same as approval by the FDA. In the issuance of an EUA, the FDA evaluates the totality of evidence and balances that in consideration of potential and known risks as well as the benefits of the product. The FDA then weighs this evidence against the need and thus authorizes the EUA based upon these findings.
“The FDA Emergency Use Authorization 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,” said Merck’s Chief Executive Officer and President Robert M. Davis. “Because we recognized the promise of Molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that Molnupiravir, now authorized, can be available to patients here in the U.S. and all around the world more quickly and more equitably than has ever been accomplished before,”
To learn more about Molnupiravir, read the fact sheets from the FDA for Healthcare Providers and for Patients and Caregivers.