FDA Grants Emergency Use Clearance for Merck’s Molnupiravir, Second Covid-19 Pill to Obtain Approval
Larry A. Watts
2 min read
(RTTNews) – The United States Food and Drug Administration on Thursday cleared a second antiviral pill to treat Covid-19, just a day after clearing the first antiviral pill for the coronavirus.
On Thursday, the FDA issued emergency use authorization for Merck’s molnupiravir (MRK) for the treatment of mild to moderate coronavirus disease. The pill has been approved for use by adults with direct viral test results positive for SARS-CoV-2 and who are at high risk of progression to severe COVID-19, including hospitalization or death.
The pill is also approved for people whose FDA-approved alternative COVID-19 treatment options are not accessible or clinically appropriate.
Molnupiravir is available by prescription only and should be started as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms.
The other day, the FDA cleared Pfizer’s paxlovin pill for Covid-19. Both pills can be taken orally at home, a breakthrough endorsement for healthcare providers as the country continues to fight the onslaught of the Delta variant as well as the highly contagious omicron variant.
“Today’s authorization provides an additional treatment option for the COVID-19 virus in the form of a pill that can be taken orally. Molnupiravir is limited to situations where other treatments approved by the FDA for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for certain patients with COVID-19 at high risk of hospitalization or deaths, ”said Patrizia Cavazzoni, MD, 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 an emergency use authorization, while continuing to generate additional data on their safety and effectiveness. “
During this time, the use of molnupiravir is not allowed in patients under the age of 18 because molnupiravir can affect the growth of bones and cartilage.
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