Merck’s anti-Covid-19 pill: European Medicines Agency launches expedited review

The European Medicines Agency (EMA) announced, Monday, October 25, the launch of the expedited review of the pill against Covid-19 by the American laboratory Merck, a remedy easy to administer and complementary to vaccines. This step, paving the way for a possible application for authorization in the European Union, comes two weeks after Merck has requested urgent authorization in the United States.

“The AEM Committee for Medicinal Products for Human Use has launched an ongoing review of the oral antiviral drug molnupiravir (…) developed by Merck (…) for the treatment of Covid-19 in adults ”, which makes it possible to speed up the procedure, the European regulator said in a statement. Antivirals like molnupiravir work by decreasing the ability of a virus to replicate, thereby slowing down the disease.

Given to patients within days of a positive test, the treatment halves the risk of hospitalization, according to a clinical trial conducted by Merck. Preliminary results from laboratory and clinical studies “Suggest the drug may reduce the ability of SARS-CoV-2 (…) to multiply in the body, thus preventing hospitalization or death in patients with Covid-19 “, said the AEM.

Separate clinical trial for preventive use

The AEM will assess the compliance of molnupiravir with the usual European standards for efficacy, safety and quality. A continuous review is a regulatory tool that the European regulator uses to speed up the evaluation of a promising drug or vaccine during a public health emergency. If approved, molnupiravir would therefore represent a major breakthrough in reducing severe forms of the disease quite easily.

This type of treatment to treat Covid-19, which can be taken at home with a glass of water, has been sought after since the start of the pandemic. Merck’s announcement in the United States two weeks ago was hailed as a major step towards this goal.

But experts have warned that this treatment is not a silver bullet and should complement vaccines, not replace them. Merck is also in the process of conducting a separate clinical trial for a second use of the treatment, as a preventative measure for people who have been in close contact with the virus to avoid developing the disease.