The committee advice allows the European Union (EU) member states to decide on the supply and use of Paxlovid, prior to EU authorisation
Pfizer announced that European Medicines Agency (EMA)’s human medicines committee (CHMP) has recommended the use of Paxlovid (PF-07321332 and ritonavir) for the treatment of Covid-19.
The CHMP guidance allows the use of Paxlovid to treat Covid-19 in adults, who are at elevated risk of disease progressing, and do not require supplemental oxygen.
Paxlovid is an investigational oral antiviral that specifically targets the activity of SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate.
Its active substance PF-07321332 works to inhibit the activity of an enzyme that facilitates the virus replication, and a low dose of ritonavir enables the breakdown of PF-07321332.
The drug is recommended for administration soon after diagnosis of Covid-19 and within five days from the start of symptoms.
EMA advice allows the European Union (EU) member states to decide on the supply and use of Paxlovid, prior to EU conditional marketing authorisation, said Pfizer.
Pfizer chairman and CEO Albert Bourla said: “The CHMP’s advice signifies the strength of our data for PAXLOVID in the treatment of high-risk adults diagnosed with Covid-19.
“Covid-19 continues to take lives at an unprecedented pace globally and exacts a devastating toll on health care systems. If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations.
“We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.”
The CHMP advice was based on positive results from the Phase 2/3 EPIC-HR interim analysis in Covid-19 patients, who are at elevated risk of severe disease.
In the study data, the drug showed an 89% reduction in risk of Covid-19-related hospitalisation or death compared to placebo, within three days of symptom onset.
Paxlovid also showed similar results in people treated within five days of symptom onset.
Results from the primary endpoint analysis of the EPIC-HR trial were consistent with the interim analysis and confirmed the efficacy and a safety profile.
Furthermore, Pfizer has initiated a rolling submission with the EMA for potential EU conditional marketing authorisation of the drug.
Once authorised, Paxlovid could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, to prevent severe illness, hospitalisation and death.