Merck Seeks FDA Emergency Authorization for First Oral COVID-19 Therapy

Video source: YouTube, CNBC Television

Drugmaker Merck & Co Inc (NYSE: MRK) and its partner Ridgeback Biotherapeutics LP announced Monday that they have requested an emergency use authorization from the US Food and Drug Administration (FDA) for their oral antiviral COVID-19 treatment.

If approved, the pill, molnupiravir, would be the first oral therapy for COVID-19 and could be a potential breakthrough on how the virus is treated since all other FDA-backed treatments require an injection or IV administration. 

The filing comes about a week after the companies released clinical trial data for the experimental drug that showed it reduced the risk of hospitalization or death by around 50% for patients with mild or moderate cases of COVID-19. 

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, chief executive officer and president of Merck, said in a statement.

The data was based on early results from 775 patients who had laboratory-confirmed symptomatic COVID-19 and were enrolled in the phase three trial by early August. According to Merck, all participants were unvaccinated and had at least one underlying factor that put them at high risk of developing a more severe case of the disease.

Molnupiravir is an orally administered form of a ribonucleoside analog that inhibits the replication of SARS-CoV-2, the coronavirus that causes COVID-19.

Following the strong results, an independent group of medical experts monitoring the trial recommended that Merck cease further studies and submit for an EUA from regulators.

Ridgeback Biotherapeutics chief executive officer Wendy Holman said in a statement on Monday, "The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19.”

With some 68 million eligible Americans still unvaccinated, public health experts believe it is crucial to develop convenient and effective drugs to control future waves of infection. Despite encouraging signs in recent weeks — such as a drop in new cases and virus-related fatalities and increasing vaccination numbers — authorities are bracing for another possible surge once cold weather drives more people inside, The Associated Press noted.

Former FDA commissioner Scott Gottlieb told CNBC last week that he believes molnupiravir is a “profound game changer.”

During an interview, Gottlieb predicted that the “pandemic phase” of coronavirus would come to an end after regulators approve vaccines for children under 12 and antiviral pills.

Earlier this year, Merck entered into an agreement with the White House to supply the US government with 1.7 million doses of molnupiravir, pending FDA authorization or approval.

A five-day course of the pill will cost the federal government about $700 per patient, cheaper than other treatments that have been rolled out specifically for COVID-19 patients, according to The Associated Press.

Merck has also agreed to sell the pills to countries including Australia, Thailand, Singapore and South Korea. 

Pfizer and Roche are also racing to develop an easy-to-administer antiviral pill for COVID-19, Reuters noted.  

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Source: Equities News