Dec. 23, 2021 – FDA Grants Emergency Use Authorization for Merck’s Molnupiravir
On December 23, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for molnupiravir, which is a treatment for COVID-19 manufactured by Merck. The EUA for molnupiravir authorizes its use for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of severe COVID-19 and who are unable to utilize alternate treatment options. While this new treatment can prevent the progression of COVID-19 in some patients, many others will be unable to benefit from the treatment. For example, patients who have already been hospitalized will be unable to benefit from molnupiravir because the treatment has only demonstrated efficacy when patients receive it before they are hospitalized. Also, the FDA notes that molnupiravir is not appropriate for patients under the age of 18 because it may affect bone and cartilage growth and the FDA recommends against administering molnupiravir to pregnant patients because findings from animal studies showed how molnupiravir can cause fetal harm. Molnupiravir is administered as four capsules taken twice a day for five days.
The full EUA can be accessed here.
Merck’s press release can be accessed here.
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Paxlovid, which is an oral antiviral treatment for COVID-19 manufactured by Pfizer. The EUA for Paxlovid authorizes its use for the treatment of adults and children over the age of 12 with mild-to-moderate COVID-19 who are at high-risk of severe COVID-19.
On October 11, 2021, Merck and Ridgeback Therapeutics announced their Emergency Use Authorization application to the U.S. Food and Drug Administration (FDA) for molnupiravir, which is an investigational oral treatment for mild-to-moderate COVID-19 in adults at risk of hospitalization.
On October 1, 2021, Merck announced the results of the planned interim analysis of the MOVe-OUT Phase 3 clinical trial, which is investigating the safety and efficacy of an oral antiviral treatment for non-hospitalized patients with mild-to-moderate COVID-19.
Pandemic Patients is a 501(c)(3) non-profit organization that works to relieve the harm caused by COVID-19 and post-COVID conditions. EIN 86-3930257.
Please consider making a charitable donation to help us advance our important work.
Prior to using this website, please review our Terms of Use and Privacy Policy.