Pfizer Inc. announced it will further strengthen its commitment to United States manufacturing with a $120 million investment at its Kalamazoo, Michigan, facility, enabling U.S.-based production in support of its COVID-19 oral treatment, PAXLOVIDTM (nirmatrelvir), according to a news release.
The investment will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir [PF-07321332] tablets and ritonavir tablets, a novel main protease (Mpro) inhibitor originating in Pfizer’s laboratories. This investment is another major step in Pfizer’s effort to bring more key biopharmaceutical manufacturing to the U.S., increasing Pfizer’s capability to produce and supply treatments and medicines for patients in the U.S. and around the world.
“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “By increasing production at our Michigan facility, we are both helping patients around the world and expanding important manufacturing innovation to the U.S. This investment builds upon our $5 billion of investments across our manufacturing and distribution portfolio since 2017 to support the ongoing growth of U.S. manufacturing leadership.”
Results from Pfizer’s EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study showed an 88% reduction in COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID compared to placebo within five days of symptom onset. PAXLOVID is currently approved or authorized for conditional or emergency use in more than 60 countries across the globe to treat high-risk COVID-19 patients.
Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Fewer serious adverse events (1.6% vs. 6.6%) and discontinuations of study drug due to adverse events (2.1% vs. 4.2%) were observed in patients dosed with PAXLOVID compared to placebo, respectively.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.