The European Medicines Agency (EMA) is examining the approval of a corona drug from the US pharmaceutical company Merck & Co. As the EMA announced on Monday, the EMA's Committee for Medicinal Products for Human Use (CHMP) is leading 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.
Two weeks ago, Merck & Co. had already applied for emergency approval in the USA.
In early October, the company and its partner published the results of a study found that molnupiravir halved the risk of hospitalization or fatal disease in infected patients.
According to this, 7.3 percent of the 385 patients with mild or moderate Covid-19 symptoms who received the antiviral drug were hospitalized during a phase 3 clinical study.
There was no death.
In the test group of 377 patients who received a placebo, 14.1 percent of the cases were hospitalized or fatal.
Eight patients died.
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, like the EMA-approved antiviral drug Remdesivir.
A continuous review process, the so-called rolling review process, enables the EMA to review data on the efficacy and safety of drugs or vaccines as soon as they are available and before the manufacturer submits a full application for approval.
This is intended to speed up the examination of an application submitted later.
The approval can still take several months.