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The European Medicines Agency (EMA) and the European Medicines Agency Network (HMA) agree that further guidance on Covid-19 treatments is needed in view of the increasing prevalence and death of Covid-19 infection across the European Union (EU).
Although a comprehensive accelerated assessment of this medicine is currently taking place before a potential marketing authorization is submitted, the Committee for Medicinal Products for Human Use (CHMP) will make recommendations to the EU as soon as possible to help national authorities decide on the possible early use of this medicine.
As explained by ZVA, molnupiravir is an oral antiviral drug developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics. They reduce the ability of the SovS-CoV-2 virus that causes Covid-19 to multiply in the body. This is done by increasing the number of mutations in the viral genetic material (known as RNA), which affects the ability of SARS-CoV-2 to multiply.
EZA and HMA remain committed to accelerating the evaluation of much-needed Covid-19 treatments and vaccines, while ensuring that they meet high standards of safety and efficacy in the EU. The ESA will provide information on the outcome of this evaluation, as well as the accelerated evaluation, as soon as it is completed.
According to ZVA, Emera Cook, Executive Director of EZA, requested this assessment in accordance with Article 5.3 of Regulation 726/2004. After initial consultation with the ESA Covid-19 Pandemic Working Group (COVID-ETF), experts from across the European Network of Medicines Agencies will work together.
The assessment is carried out by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for matters relating to medicines for human use. The Committee will provide a scientific opinion as soon as possible so that EU Member States can take this into account when deciding on the use of this medicine at national level before it is officially authorized.
This evaluation will be carried out in parallel with the accelerated evaluation of the quality, efficacy and safety data for this medicine, which will allow the application for registration of this medicine to be submitted if it is satisfactory.
ZVA experts also participate in ESA committees and working groups.
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