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Molnupiravir: Ema is examining approval of a corona drug from Merck & Co.

2021-10-25T13:37:45.008Z


It could be the first pill against Covid-19: The European Medicines Agency Ema has started to evaluate data on a corona drug from Merck & Co. The first study results were promising.


Enlarge image

Pills of the still experimental Covid-19 drug molnupiravir

Photo: Merck & Co / REUTERS

The European Medicines Agency (Ema) is reviewing the approval of a corona drug from the US pharmaceutical company Merck & Co. As the agency announced on Monday, its Committee for Medicinal Products for Human Use (CHMP) is conducting an ongoing review process for the drug molnupiravir for the treatment of adult Covid -19 patients. Molnupiravir is an antiviral drug in pill form that was developed by Merck & Co. together with Ridgeback Biotherapeutics.

About two weeks ago, Merck & Co. had already applied for an emergency approval for the product in the USA.

In early October, the company and its partner published interim results of a study according to which molnupiravir roughly halved the risk of hospitalization or fatal disease in infected patients.

The remedy works by disrupting the growth of viruses in the body.

If the disease is already advanced, the pills are no longer beneficial.

According to the manufacturer, the pill halves the risk of a severe course

According to a press release, during a phase 3 clinical trial with molnupiravir, data were collected from 775 people who were mildly or moderately ill with Covid-19 in different parts of the world and who had at least one risk factor for a severe course. These included old age or cardiovascular disease. At the latest on the fifth day after the onset of the symptoms, the participants received either the drug or a placebo.

In the experimental group of 385 patients who received the antiviral drug, 7.3 percent were hospitalized. There was no death. In the test group of 377 patients who received a placebo, 14.1 percent of those infected came to the hospital or had a fatal outcome. Eight people died. Little is known about the possible side effects of the drug.

The ongoing testing process that has now been started, the so-called rolling review process, enables Ema to review data on the efficacy and safety of drugs or vaccines as soon as they are available and before the manufacturer has submitted a complete application for approval. The procedure is intended to accelerate the examination of a later submitted application for approval. The process can still take several months.

A number of pharmaceutical companies are currently working on antiviral drugs against Covid-19.

Such drugs are designed to prevent viruses from entering body cells or multiplying there.

Molnupiravir is considered to be particularly promising because it can be taken as a pill and does not have to be administered intravenously, such as the antiviral drug Remdesivir, which has already been approved by Ema.

Vaccination continues to provide the best protection against a severe course of Covid-19.

irb / AFP

Source: spiegel

All tech articles on 2021-10-25

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