Pfizer Canada announced today that Health Canada has authorized the use of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults (18 years of age and older) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The treatment includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate.
"We are very proud to share this news with Canadians today. As our healthcare system and hospitals face significant pressures in this ongoing pandemic, this new treatment will provide a new option in the management of COVID-19," said Kevin Mohamed, Pfizer Canada Hospital Business Unit Lead.
"Pfizer is ready to begin delivery in Canada immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible."
Health Canada based its decision on clinical 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. 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.
With PAXLOVID now authorized, Pfizer is ready to begin delivering the product across Canada. In December 2021, Pfizer announced an agreement with the Government of Canada to supply one million treatment courses of PAXLOVID in 2022.
About PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts COVID-19.
PAXLOVID is authorized to be administered twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Consult the PAXLOVID product monograph for dosing instructions and other conditions of use.
SOURCE: Pfizer Canada Inc.