This step, paving the way for a possible application for authorization in the European Union, occurs two weeks after the US laboratory has requested an emergency authorization in the United States.
Le Monde with AFP
The European Medicines Agency (AEM) announced, Monday, October 25, the launch of the accelerated examination of the CVIV-19 pill of the American Merck laboratory, an easy cure to administer and complementing vaccines. This step, paving the way for a possible request for authorization in the European Union, occurs two weeks after Merck requested an emergency authorization in the United States.
“The Human Medicines Committee of the AEM has launched a continuous review of the Oral Molnupiravir (…) antiviral drug (…) developed by Merck (…) for the treatment of CVIV-19 in adults”, which allows ‘Accelerate the procedure, said the European regulator in a statement. Antivirals like molnupiravir act by reducing the capacity of a virus to replicate, thus braking the disease.
Given to patients in the few days following a positive test, the treatment reduced by two hospitalization risks, according to a clinical trial conducted by Merck. Preliminary Laboratory Studies and Clinical Studies Results “suggest that the drug can reduce the capacity of SARS-COV-2 (…) to multiply in the body, thus preventing hospitalization or death in patients with affected patients. COVID-19, “said AEM.
Separate clinical trial for a use as a preventive capacity
EMA will evaluate the compliance of molnupiravir with usual European standards for efficiency, safety and quality. Continuous review is a regulatory tool that the European regulator uses to accelerate the evaluation of a promising drug or vaccine at a public health emergency. If approved, molnupiravir would thus represent a major breakthrough by making it easy to reduce the serious forms of the disease.