US pharmaceutical company Pfizer said on November 16 that it requested the Federal Drug Administration (FDA) to issue emergency use authorization for its Paxlovid COVID-19 medication.
“Pfizer Inc. today announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death,” a statement said.
Reports said that Paxlovid could be prescribed as an at-home treatment to high-risk patients.
Recent clinical studies show the overwhelming efficacy of the new medicine, Pfizer CEO Albert Bourla said.
“Its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” he added.
Pfizer is seeking EUA based on positive results from interim analysis, which included data from non-hospitalized adults. “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,” the statement read.