U.S. pharmaceutical company Pfizer announced Friday its new COVID-19 pill showed an 89% reduction in risk of COVID-19-related hospitalization or death in clinical trials and they plan to submit the drug to U.S. regulators for emergency use approval.
In a release Friday, Pfizer said the latest clinical trials of its pill, Paxlovid, featured a randomized, double-blind study of non-hospitalized adult patients with COVID-19 who are at high risk of progressing to severe illness.
The company said interim analysis of the oral antiviral showed an 89% reduction in risk compared to a placebo in patients treated within three days of symptom onset.
Pfizer said it has received an independent data monitoring committee recommendation to pause enrollment in the Phase 3 trial due to the overwhelming efficacy demonstrated in the latest results.
The company plans to submit the data as part of its ongoing application to the FDA for Emergency Use Authorization as soon as possible.
Pfizer is now the second drug manufacturer to develop an oral treatment for COVID-19. U.S. company Merck last month introduced its COVID-19 pill, which clinical studies showed to provide a 50% reduction in hospitalizations and deaths due to COVID-19. It has been submitted to the FDA, and the federal agency is scheduled to rule on it late this month.
Currently, all COVID-19 treatments approved in the United States require injection or intravenous drip. Pills have the advantage of being distributed by pharmacies and taken at home.
Britain’s Medicines and Healthcare products Regulatory Agency approved Merck’s pill, known as Molnupiravir, Thursday. The European Union’s drug regulator, the European Medicines Agency (EMA), said it would speed up its review of the Merck pill, and is prepared to give advice to individual EU member states so they can make the pill available for emergency use ahead of the EMA authorization.
When Merck’s pill was submitted for approval last month, White House Coronavirus Response Coordinator Jeff Zients said the U.S. government had already arranged to buy 1.7 million doses of the pill, with an option to acquire more if needed.
