- FDA advisory committee votes in favor of emergency use authorization of Merck & Co.’s pill to treat mild to moderate COVID-19 patients
- The drug, molnupiravir, stops viruses such as the coronavirus from making copies of itself and spreading throughout the body.
- The next step is approval by the FDA and signing by the CDC before the pill is distributed.
- An analysis published Friday found that mollupiravir can reduce the risk of hospitalization and death by up to 30%.
A US Food and Drug Administration (FDA) advisory committee on Tuesday recommended emergency use authorization of Merck & Co.’s experimental pill to treat mild to moderate COVID-19 patients.
A medicine called molanupiravir stops the virus from making copies of itself, which stops it from spreading throughout the body.
Recent trial data has shown that it can reduce the risk of death or hospitalization by up to 30 percent for people at high risk of severe COVID-19.
On Tuesday, the Antimicrobial Drugs Advisory Committee (AMDAC) voted 13-10 in favor of the drug.
The FDA is not obligated to follow the advisory group’s recommendations but the agency rarely goes against the group’s guidance.
If authorized by the FDA and signed off by the Centers for Disease Control and Prevention (CDC), Merck’s drug could be the first oral antiviral drug for COVID-19 — and instead of requiring patients to take the drug at home Medicines may be allowed. in a hospital for treatment.
FDA advisory committee votes in favor of emergency use authorization of Merck & Co.’s pill to treat mild to moderate COVID-19 patients
The drug, molnupiravir, 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.
In a preliminary analysis, the study tracked 775 adults with mild to moderate COVID-19 who were considered at high risk for severe illness 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 who got the dummy pill — the risk was cut in half.
An analysis published Friday found that mollupiravir can reduce the risk of hospitalization and death by up to 30% (up).
However, the final analysis was published Friday ahead of the FDA advisory committee meeting. More than 1400 participants were included.
The participants were divided into two groups, one of One received the drug and the other was given a placebo.
The researchers found that 9.7 percent of the control group had to face a severe case of COVID to cause hospitalization or death – for a reduction of 30 percent, compared to only 6.8 percent of the control group.
Last month, the United Nations-backed public health group, Medicines Patent Pool, struck an agreement with Merck to distribute its pill.
Merck is partnering with generic manufacturers around the world to mass-produce and distribute the drug, and the deal with Medicines Patent Pool will allow the health group to sub-license the drug.
Unless the World Health Organization considers COVID-19 a global emergency, no drug maker will receive royalties under the agreement.
An antiviral pill that people could take at home to ease their symptoms and speed recovery could help ease crushing caseloads on hospitals and contain outbreaks in poor countries with weak health care systems.
It will quickly become the best option for treating the virus, as it is effective and much easier to administer than the popular monoclonal antibody therapies.
It will also strengthen a two-pronged approach to epidemics: treatment and prevention through medicine, primarily through vaccination.
In response to the promising data, France has ordered 50,000 doses of the drug.
The US also plans to make a major purchase soon, with an order for 1.7 million doses pending FDA authorization.