Molnupiravir: Great Britain approved first, EMA is in a hurry and allows not to wait

The European Medicines Agency last week began evaluating the Covid-19 antiviral drug and is trying to speed it up. The UK already approved its use on Thursday and became the first country in the world to recommend Merck tablets for the treatment of coronavirus.

Sajid Javid, Britain’s Minister of Health, is optimistic:

“Today is a historic day for our country. The UK is the first in the world to approve an anti-covid antiviral drug that can be taken at home.”

Javid notes that the drug “Molnupiravir” in tablets will be prescribed to the most vulnerable patients, it needs to be taken twice a day. He is able to save people with fragile health or weak immune systems. Three-stage clinical trials have shown that it reduces mortality and hospitalization risk for Covid-19 by 50%.

The manufacturing company announced the creation of a drug for the treatment of coronavirus in March this year. It was originally developed as an anti-influenza remedy. Air force… However, large-scale trials involving 775 people have demonstrated its effectiveness in treating coronavirus. An interim analysis of the Phase III study showed:

7.3% of patients receiving Molnupiravir were hospitalized within 29 days; of patients receiving placebo, 14.1% were hospitalized or died by the 29th day; there were no deaths among those who received the drug within 29 days; among those receiving placebo, 8 deaths were recorded.

The trial involved patients with laboratory-confirmed Covid-19. They randomly received either Molnupiravir or a placebo within 5 days of symptom onset. Each of them was not vaccinated and had at least one aggravating factor for the coronavirus: age 60+, obesity, diabetes, cardiovascular disease.

“Molnupiravir” was developed by scientists from the US National Institutes of Health and the University of Plymouth, the newspaper says. News… In a nutshell, its action can be described as follows: a drug molecule disrupts the process of viral RNA replication and leads to copying errors. That is, when the coronavirus reproduces, it creates a copy of its own RNA, but this drug invades the new RNA, giving it an indication to self-destruct, clearing the human body of the virus.

The European Medicines Agency yesterday announced its intention to speed up the evaluation of the drug, as Europe is currently facing a growing new wave of coronavirus. Marco Cavaleri, EMA’s head of vaccination strategy, said yesterday:

“We will try to expedite our assessment to get approval as soon as possible.”

At the same time, he found it difficult to name the exact date, but AFP quotes him as saying about the possibility of early application:

“We are also committed to recommending that EU member states provide them with access to this new oral emergency pill before it is approved.”

In fact, Molnupiravir, approved yesterday by the UK and will no doubt soon be approved by the EMA, is first pills against the coronavirus in the market. It has already been proven that this treatment halves hospitalizations and deaths. It is important to start using it as soon as possible if a diagnosis is made and symptoms appear – within five days.

Merck previously agreed to supply about 1.7 million courses of molnupiravir to the United States, after receiving emergency use or full approval from the FDA. The company also, pending regulatory approval, has entered into agreements and is in negotiations for the supply and procurement of the drug with the governments of many countries, including – with Greece

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