FDA Gives Emergency Use Authorization For Merck's Molnupiravir, Second Covid-19 Pill To Get Approval

(RTTNews) - The U.S. Food and Drug Administration on Thursday authorized a second anti-viral pill to treat Covid-19, just a day after authorizing the first antiviral pill for the coronavirus.

On Thursday, FDA issued an emergency use authorization for Merck's (MRK) molnupiravir for the treatment of mild-to-moderate coronavirus disease. The pill has been approved for use by adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The pill is also approved for whom alternative COVID-19 treatment options authorized 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 five days of symptom onset.

The other day, FDA authorized Pfizer's paxlovin pill for Covid-19. Both pills may be taken orally at home, a breakthrough approval for the health care providers as the country continues to fight the onslaught of Delta variant as well as the highly contagious omicron variant.

"Today's 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."

Meanwhile, molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth.