Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued advice on the use of Paxlovid (nirmatrelvir and ritonavir tablets), stating that Paxlovid can be used to treat adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The CHMP also recommend that Paxlovid should be administered as soon as possible after diagnosis of Covid-19 and within five days of the start of symptoms. The EMA issued this advice under Article 5(3) of Regulation 726/2004 to support authorities of European Union (EU) Member States who may decide to allow the supply and use of PAXLOVID, for example in emergency use settings, prior to EU conditional marketing authorization. PAXLOVID is currently not authorized for use in the EU.

“The CHMP’s advice signifies the strength of our data for Paxlovid in the treatment of high-risk adults diagnosed with Covid-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

The CHMP based their advice on positive results from the Phase 2/3 EPIC-HR interim analysis, which enrolled non-hospitalized adults with confirmed Covid-19 who are at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in risk of Covid-19-related hospitalization or death from any cause in patients treated with Paxlovid compared to placebo within three days of symptom onset, with no deaths in the treatment group. Similar results were seen with those treated within five days of symptom onset.

Pfizer has also initiated rolling submission with the EMA for potential EU conditional marketing authorization of Paxlovid. If authorized, it could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.