The European Medicines Agency’s (EMA) regulatory Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s COVID-19 treatment, Paxlovid, recommending conditional marketing authorisation (CMA).
The CMA for Paxlovid (nirmatrelvir tablets and ritonavir tablets) is specifically to treat adult patients with COVID-19 who do not require supplemental oxygen and are at an increased risk of becoming severely ill.
The CHMP recommendation is based on phase 2 and phase 3 data from the EPIC-HR trial.
The trial involved non-hospitalised adults aged 18 and above with confirmed cases of COVID-19, who had an increased risk of becoming severely ill.
The trial data showed a reduced risk of hospitalisation or death of 89%, if taken within three days of developing symptoms, and 88% compared to placebo, if taken within five days of developing symptoms. No deaths were observed in the treatment group.
Paxlovid is an orally administered drug that should be given at the first sign of infection and is currently approved or authorised for emergency use in more than ten countries worldwide.
Phase 2 and 3 trials are currently ongoing in adults who have a low risk of hospitalisation or death and for those who’ve been exposed to COVID-19 at home.
“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, Pfizer’s chairman and chief executive officer.
Bourla added: “Pending conditional marketing authorisation 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.”