According to the interim clinical trial results announced Friday, Merck & Co Inc’s (MRK.N) experimental oral drug for COVID-19, molnupiravir, lowered the risk of hospitalization and death for patients at risk of severe disease by roughly 50%.
Merck and its partner Ridgeback Biotherapeutics plan to apply for emergency use approval in the United States as soon as possible, as well as applications to regulatory agencies around the world. On the recommendation of outside monitors, the Phase 3 trial will be stopped early due to positive results.
Robert Davis, Merck’s chief executive officer, told Reuters, “This is going to change the dialogue around how to manage COVID-19.”
Molnupiravir, which is meant to create errors in the virus’s genetic code, would be the first oral antiviral drug for COVID-19 if it is approved.
Merck’s stock rose over 8% in pre-market New York trade as a result of the announcement.
Rivals such as Pfizer Inc (PFE.N) and Roche Holding AG (ROG.S) are racing to create an easy-to-administer COVID-19 antiviral pill, but only antibody combinations – which must be given intravenously – are currently approved for treating non-hospitalized COVID-19 patients.
According to a planned interim analysis of 775 participants in Merck’s research,7.3% of patients treated with the drug were hospitalized within 29 days. In comparison, 14.1% of placebo patients were hospitalized or died by day 29. There were no deaths in the molnupiravir group, whereas eight deaths occurred in the placebo group.
“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.
Scientists applauded the possibility of a new medication to help avoid major diseases from the virus, which has claimed the lives of almost 5 million people worldwide.
Professor Penny Ward, Independent Pharmaceutical Physician, said, “The availability of a well-tolerated, effective oral antiviral will be particularly useful in supplementing vaccination as a means to reduce the proportion of patients needing hospital care.”
Molnupiravir was administered every 12 hours for five days in the experiment, which enrolled patients from all around the world.
Patients with mild-to-moderate COVID-19 who experienced symptoms for less than five days participated in the trial. At least one risk factor for poor illness outcomes, such as obesity or advanced age, was present in all of the patients.
According to Merck, viral sequencing has shown that molnupiravir is effective against all coronavirus variations, including the highly transmissible Delta.
The company stated that the rates of adverse events for both molnupiravir and placebo patients were similar but did not elaborate on the side effects.
Merck intends to produce 10 million courses of medication by the end of 2021, with more doses arriving the following year.
The company has a contract with the US government to offer 1.7 million molnupiravir courses at the cost of $700 per course.
Merck has similar arrangements with other governments throughout the world, according to CEO Davis, and is in talks with others. According to the corporation, a tiered pricing system based on country income criteria will be implemented.
Merck has also agreed to license the medicine to a number of generic drugmakers located in India, who will be allowed to supply it to low- and middle-income countries.
Molnupiravir is also being tested in a Phase 3 trial to see if it can prevent coronavirus infection in persons who have been exposed to it.
Officials from Merck said they don’t know how long the FDA will take to assess the medicine.
Dean Li, head of Merck’s research labs, said “I believe that they are going to try to work with alacrity on this.”
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