European Medicines Agency to begin evaluation of Merck laboratory’s COVID-19 pill

The European Medicines Agency (EMA) said on Tuesday that could begin in a few days the evaluation of a pill produced by the American laboratory Merck against the COVID-19, paving the way for a possible application for authorization in the European Union.

“We are proposing to launch a continued review of this compound in the coming days”Said Marco Cavaleri, EMA’s vaccine strategy manager.

Merck claimed last week that, according to a clinical trial, its medicine called molnupiravir halved the risk of hospitalization and death of patients affected by COVID-19, which would mean a major step forward in the fight against the pandemic.

The Amsterdam-based EMA has taken note of the “first results reported by the company” Merck about this new drug, Cavaleri added at a press conference.

This American laboratory announced on Friday that He intends to seek approval from the United States to market the pill shortly.

The clinical trial of Merck and its partner Ridgeback Biotherapeutics was conducted in 775 people recognized as mild to moderate cases of COVID-19, with at least one aggravating risk factor. They received the treatment five days after the first symptoms appeared.

The rate of hospitalization or death in patients who received the drug was 7.3%, compared to 14.1% among those who received the placebo. No deaths were found in people treated with molnupiravir, against eight in the second group.

As a result, Merck announced on Friday that its oral treatment has been reduced by approximately 50% the risk of hospitalization or death in patients with this disease. “If the use is authorized, Molnupiravir May Be First Oral Antiviral Drug For COVID-19″ Added signature.

Molnupiravir is administered by orally and works by preventing the coronavirus from replicating inside the body.

“They are urgent more tools and treatments to fight the covid-19 pandemic, which has become the leading cause of death and continues to deeply affect patients, families and societiesRobert Davis, president of Merck & Co, said in a statement.

“With these impressive results we are optimistic that molnupiravir could become an important drug in the global effort to fight the pandemic “added.

The results of the study were published by the company and have not been peer reviewed.

So far, the FDA has only approved one antiviral treatment for COVID 19, the remdesivir, but this is administered intravenously, in hospitals, in already severe cases. The pill would be something much simpler, accessible to all types of patients.

(With information from AFP and EFE)

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