Pfizer Inc. 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 (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.
“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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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.”
The CHMP based its positive opinion on the scientific evidence supporting PAXLOVID, including data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. The data showed that PAXLOVID reduced the risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo, with no deaths observed in the treatment group. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. The data have been submitted to a peer-reviewed publication. Additional Phase 2/3 clinical trials are ongoing in adults at standard risk (i.e., low risk of hospitalization or death) of progressing to severe illness, and in those who have been exposed to the virus through household contacts.
PAXLOVID is currently approved or authorized for emergency use in more than 10 countries across the globe. In December, the CHMP issued advice under Article 5(3) of Regulation 726/2004 to support authorities of European Union (EU) Member States regarding the potential supply and use of PAXLOVID prior to EU conditional marketing authorization.