- Merck & Company asks FDA for emergency use authorization of its pill to treat mild to moderate COVID-19 patients
- The drug, molnupirvir, stops viruses such as the coronavirus from making copies of itself and spreading throughout the body.
- One study found that 7.3% of the treatment group were either hospitalized or died at the end of 30 days, compared to 14.1% who received the dummy pill.
- If approved by the FDA, molnupiravir would be the first pill shown to treat COVID-19, and patients would be able to take the drug at home.
Merck & Co. announced on Monday that it has applied for emergency use authorization with the US Food and Drug Administration (FDA) for an experimental pill to treat mild to moderate COVID-19 patients.
A medicine called molunpiravir stops the virus from making copies of itself, which stops it from spreading throughout the body.
Recent trial data has shown that it can halve the chances of death or hospitalization for people who are at risk of contracting a severe case of COVID.
If authorized, Merck’s drug could be the first oral antiviral drug for COVID-19 — and allow patients to take the drug at home instead of needing to go to a hospital for treatment.
Merck & Company asked the FDA for emergency use authorization of its pill — the very first — to treat mild to moderate COVID-19 patients. Pictured: A merch sign stands in front of the company building in Summit, New Jersey
The drug, molnupiravir (pictured), stops viruses such as the coronavirus from making copies of itself and spreading throughout the body
Molnupiravir is an antiviral drug that was developed at Emory University in Atlanta by its drug innovation company, Drug Innovation Ventures at Emory (DRIVE), which was licensed by Ridgeback Biotherapeutics LP, which partnered with Merck.
It was originally intended to treat influenza and prevent the virus from making copies of itself by making errors during viral RNA replication.
Animal studies conducted last year found that mollupiravir can completely suppress viral transmission and prevent and reduce severe lung damage.
The new study tracked 775 adults with mild to moderate COVID-19 who were considered at high risk for severe disease because of health problems such as obesity, diabetes or heart disease.
Among patients taking molanupiravir, 7.3 percent were either hospitalized or died at the end of 30 days, compared with 14.1 percent of those taking the dummy pill.
According to Merck, there were no deaths in the drug group after that time period, compared to eight deaths in the placebo group.
The results were released by the company and have not been reviewed, but Merck says it plans to present them at a future medical meeting.
An independent group of medical experts overseeing the trial recommended stopping it early because the interim results were so strong.
“I wondered what the drug might be able to do in this clinical trial,” Dr. Dean Lee, Merck Research vice president, told the Associated Press.
‘When you see a 50 percent reduction in hospitalizations or deaths, that’s a substantial clinical effect.’
Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Interim efficacy data on the drug had a huge impact on stocks of COVID-19 vaccine makers when it was released last week.
The current drugs, Gilead Sciences Inc.’s infused antiviral remdesivir and the generic steroid dexamethasone, are usually given only after a patient is hospitalized.
Monoclonal antibody drugs from Regeneron Pharmaceuticals Inc. and Eli Lilly have seen only limited use so far because of the difficulty of administering them.
In India, however, two drugmakers last week sought to end late-stage trials of their generic versions of molnupiravir to treat moderate COVID-19, according to study documents.
A source in the Drug Controller General of India had said that the pill has not shown a ‘significant effect’ against moderate cases, but has been successful against mild cases.
Merck said its tests are based on FDA definitions that give blood oxygen levels of no less than 93 percent for moderate COVID-19, while tests in India give the medium as blood oxygen levels of 90 percent and 93 percent. define between.