FDA Expert Panel recommends molnupiravir

AmericaTen out of 13 members of the Food and Drug Administration’s (FDA) Advisory Council voted on November 30 in favor of the agency’s approval of the antiviral drug molnupiravir.

With this move, molnupiravir could be approved in the US within the next few days and be in official use before the end of the year. The drug is intended for patients who are elderly or have epidemiological reasons that put them at risk of severe disease. However, the FDA recommends that pregnant women not use molnupiravir, noting that to date there have been no clinical trials of this drug in pregnant women. Tests with molnupiravir performed in pregnant rats and rabbits showed the possibility of low birth weight and birth defects if the mother took this product.

On November 26, pharmaceutical company Merck said the antiviral drug molnupiravir reduced the risk of hospitalization and death in Covid-19 patients by 30%, lower than previous estimates of 50%.

The latest data come after an analysis of 1,400 patients. Accordingly, in the last trial, people taking molnupiravir had a 6.8% risk of hospitalization, one patient died. The placebo group had a 9.7% risk of hospitalization and 9 deaths.

Dr. David Boulware, an infectious disease expert at the University of Minnesota, expects the regulator to approve the drug. “The effectiveness of the drug is slightly reduced, but there is still a great benefit in preventing deaths if treatment is started early,” he said.

He said molnupiravir can be considered as a low-grade drug, an alternative for people who cannot use other methods.

The antiviral drug molnupiravir is developed by two companies Merck and Ridgeback Biotherapeutics. Photo: Reuters

Molnupiravir interrupts the process of nCoV replication. It copies a building block of viral genetic material. Therefore, when the virus reproduces, it “mistakes” to combine with the RNA of the drug. This creates errors in the genetic code. Accumulating enough errors, nCoV stops reproducing and is completely eliminated in the human body.

The UK was the first country in the world to approve molnupiravir on November 4. The UK Medicines and Healthcare products Regulatory Agency (MHRA) said its trials showed the drug was “safe and effective in reducing the risk of hospitalization and death in mild to moderate Covid-19 cases”. on average, people who are at risk of developing severe symptoms”.

Based on clinical trial data, the drug is most effective when taken in the early stages of Covid-19 and the MHRA recommends taking it within 5 days of symptom onset. The drug is also approved for use in people with at least one risk factor for developing severe disease, including obesity, older age, diabetes, and heart disease.

Merck is expected to produce 10 million courses of medicine by the end of the year, and output will increase in 2022. In June, the pharmaceutical company signed a supply agreement worth $1.2 billion with the US government. Accordingly, the country will receive medicine for 1.7 million treatment courses. Merck plans to price drugs on a tiered basis, based on World Bank (WB) income criteria, in line with each country’s finances during the pandemic.

Molnupiravir is also being tested in phase 3 in Vietnam, being piloted by the Ministry of Health into the home F0 treatment bag. The effectiveness of the drug, initially assessed by the Ministry of Health, is to help reduce the viral load for patients who take the drug at an early stage with symptoms, prevent the risk of exacerbation, hospitalization and reduce mortality.

Chile (Follow WSJ, AFP)


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