The positive CHMP recommendation was based on evidence supporting Paxlovid, including data from the Phase 2/3 EPIC-HR trial
Paxlovid is a SARS-CoV-2 Mpro inhibitor. (Credit: PIRO4D from Pixabay.)
The European Medicines Agency (EMA) has recommended the approval of Pfizer’s oral antiviral Paxlovid (nirmatrelvir plus ritonavir) to treat Covid-19 in adults.
EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on granting a conditional marketing authorisation (CMA) for Paxlovid.
The drug was indicated for treating Covid-19 in adults, who do not require supplemental oxygen and are at elevated risk for progressing to severe disease.
Paxlovid is a SARS-CoV-2 main protease (Mpro) inhibitor, also called SARS-CoV2 3CL protease inhibitor therapy, intended to be administered at the first sign of infection.
Nirmatrelvir, which has been created in Pfizer laboratories, is said to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate.
Its co-administration with a low dose of ritonavir would slow the metabolism of nirmatrelvir, enabling it to remain active in the body for a longer time at higher concentrations.
Prizer said that current variants of concern can be resistant to therapies that work by binding to the spike protein on the surface of the SARS-CoV-2 virus.
However, its Paxlovid works intracellularly by binding to the highly conserved Mpro of the SARS-CoV-2 virus to inhibit viral replication.
Pfizer chairman and CEO Albert Bourla 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.”
The CHMP recommendation was based on positive evidence supporting Paxlovid, including data from the Phase 2/3 EPIC-HR trial.
The study enrolled non-hospitalised adults, aged 18 and above, with confirmed Covid-19 who are at increased risk of progressing to severe illness.
In the trial, the treatment using Paxlovid reduced the risk of hospitalisation or death by 89%, within three days, and 88% within five days from symptoms onset, compared to placebo.
Paxlovid is currently approved or authorised for emergency use in more than 10 countries.
Last month, the US Food and Drug Administration (FDA) granted an emergency use authorisation (EUA) for Paxlovid to treat Covid-19 in at-risk adults and children, aged 12 years and above.