Pfizer Europe has submitted an application to the European Medicines Agency (EMA) on Monday for a review of its new oral COVID-19 drug called Paxlovid, a necessary step before the drug can be granted a marketing authorization in the European Union
MOSCOW (Pakistan Point News / Sputnik - 10th January, 2022) Pfizer Europe has submitted an application to the European Medicines Agency (EMA) on Monday for a review of its new oral COVID-19 drug called Paxlovid, a necessary step before the drug can be granted a marketing authorization in the European Union.
"The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19," the EMA said in a statement.
The regulator will expedite the assessment of the benefits and risks of Paxlovid and will reach a decision within few weeks, given all necessary documents have been submitted. The EMA's human medicines committee has already started a review of the data on the medicine during a rolling review, including data from laboratory, animal and clinical studies, the statement said.
If the EMA confirms that the benefits of the drug outweigh the risks, it will coordinate with the European Commission to fast track the decision granting marketing authorization in the European Union.
