Pharmaceutical giant Pfizer has prepared the first shipments of its COVID-19 oral antiviral pill, which “significantly” reduces the risk of hospitalization and death for high-risk patients, and sent them to the airport for distribution across Europe and America pending approval, it announced Tuesday.
“Thrilled to see the first shipments of our COVID-19 antiviral candidate head to the airport for distribution across Europe and the United States,” the company wrote on Twitter. “Approval or authorization could be a big step forward in helping end this pandemic.”
The drug, known as PAXLOVID, was found in a scheduled interim analysis to reduce the risk of hospitalization or death from the COVID-19 virus by 89 percent if the patient receives the drug in time, according to a company press release published on Nov. 5.
Antivirals, just like Merck’s molnupiravir, need to be given to patients as early as possible to be most effective, best within days of the onset of symptoms.
Pfizer said it plans to submit interim trial results for PAXLOVID, which is given in combination with an older antiviral called ritonavir, to the U.S. Food and Drug Administration (FDA) as part of the emergency use application it opened in October 2021.
The company submitted the application for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death to the FDA in the middle of November.
The submission included clinical data from Phase 2/3 of the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients interim analysis.
Albert Bourla, Pfizer’s chief executive, called the results “a real game-changer,” adding that the data collected shows that the companies’ oral antiviral, if approved by U.S. regulators, “has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”
“With more than 5 million deaths and countless lives impacted by this devastating disease globally, there is an urgent need for life-saving treatment options. The overwhelming efficacy achieved in our recent clinical study of PAXLOVID, and 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,” said Bourla.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application, along with other regulatory agencies around the world.”
The company did not detail the side effects of the treatment but said adverse events happened in about 20 percent of both treatment and placebo patients, most of which were mild in intensity. Ritonavir’s possible side effects include nausea and diarrhea.
A similar oral pill treatment from Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics was endorsed by the FDA on Thursday, the company announced.
The investigational oral antiviral pill treats mild to moderate COVID-19 in adults who have tested positive for the virus and are at high risk of severe side effects while reducing the risk of hospitalization.