Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing authorization (CMA) of Pfizer’s PAXLOVID™.
The EMA specified that Paxlovid has been recommended:
Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating COVID-19. It contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of PF-07321332 enabling it to remain longer in the body at levels that affect the multiplication of the virus.
Albert Bourla, Pfizer’s Chairman and Chief Executive Officer said:
This expression of confidence in PAXLOVID comes at a critical moment as Europe addresses the ongoing challenges of the pandemic and as infection rates are on the rise in many countries across the globe.We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of PAXLOVID globally. Pending conditional marketing authorization from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible.
PAXLOVID is currently approved or authorized for emergency use in more than 10 countries across the globe