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Merck Applies For Emergency FDA Approval of COVID Pill Treatment

Merck made a formal request for Emergency Use Authorization from the FDA Monday for its COVID-19 pill treatment, known as molnupiravir.

Merck  (MRK) - Get Merck & Co., Inc. (MRK) Report said Monday it has submitted a formal application to the Food & Drug Administration for emergency approval of its oral COVID treatment. 

Merck said it's seeking Emergency Use Authorization for the pill, known as 'molnupiravir', for treatment of "mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization." The Biden Administration, in fact, has already committed in June to buying 1.7 million doses -- worth around $1.2 billion -- if the drug is ultimately authorized.

Merck, which developed the oral treatment with Ridgeback Biotherapeutics, said the treatment significantly reduced the risk of hospitalization or death" in patients participating in a late-stage trial. Molnupiravir, or MK-4482, is designed to induce so-called "copying errors" within a harmful virus that prevent it from replicating in the human body.

“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,” said Merck CEO Robert Davis. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients."  

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"We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible,” he added.

Merck shares were marked 0.12% higher in early trading Monday to change hands at $80.75 each.