The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid.
CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease.
CHMP also stressed the importance of administering Paxlovid as soon as possible after a COVID-19 diagnosis to boost efficacy.
The guidance, which proceeds marketing authorization, could inform health officials’ planning efforts for Paxlovid.
“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, Pfizer CEO, in a press release. “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.”
Interim Phase 3 data showed that Paxlovid reduced the risk of COVID-19-related hospitalization or death by 89%. Final data was in a similar range.
EMA started a review of Paxlovid in November.
Also in November, EMA released feedback concerning the use of Merck’s Lagevrio (molnupiravir). To date, that drug has not won marketing authorization in the European Union.
Filed Under: clinical trials, Drug Discovery, Infectious Disease