Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients.

Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway.

The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset.

The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible US residents will continue to receive the medicine at no charge.

Paxlovid remains available for eligible children aged 12 to 17 years and weighing at least 40kg, under the existing FDA emergency use authorisation.

Albert Bourla, chairman and chief executive officer of Pfizer, said: “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern.”

Bourla added that the approval marks a “monumental milestone” as Paxlovid becomes the first COVID-19 oral treatment to be approved by the FDA.

Meanwhile, Gilead’s Veklury (remdesivir) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) to treat COVID-19 patients with severe renal impairment, including those on dialysis.

Veklury is already indicated in the European Economic Area to treat both hospitalised patients with COVID-19 and for those at increased risk of developing severe disease, but its use has previously been restricted among patients with severe renal impairment due to insufficient data.

The positive opinion was based on results from a phase 1 pharmacokinetic study, Gilead said, as well as results from the phase 3 REDPINE trial that evaluated the safety of Veklury in patients hospitalised for COVID-19 with severe renal impairment.

The European Commission will now review the CHMP’s recommendation and, if adopted, Veklury will become the first and only authorised antiviral COVID-19 treatment that can be used across all stages of renal disease.

Reference：
https://www.pmlive.com/pharma_news/covid-19_pfizers_paxlovid_approved_by_fda_and_gileads_veklury_recommended_by_chmp_1492125