US pharmaceutical company Pfizer announced on Friday that its new COVID-19 pill has shown an 89% reduction in the risk of hospitalization or death due to COVID-19 in clinical trials, and they plan to submit the drug to US regulators for emergency use. …
In Friday’s issue, Pfizer said the latest clinical trials of its pill, Paxlovid, included a randomized, double-blind study of non-hospitalized adult COVID-19 patients who are at high risk of progression to severe illness.
The company said an interim analysis of an oral antiviral drug showed an 89% risk reduction compared to placebo in patients treated within three days of symptom onset.
Pfizer said it received a recommendation from an independent data monitoring committee to suspend participation in the Phase 3 study due to the tremendous effectiveness demonstrated in the latest results.
The company plans to provide data as soon as possible as part of its current FDA filing for an emergency use authorization.
Pfizer is the second drug manufacturer to develop an oral drug for the treatment of COVID-19. US company Merck unveiled its COVID-19 pill last month, with clinical studies showing a 50% reduction in hospital admissions and deaths due to COVID-19. It has been filed with the FDA and is due to be ruled by the federal agency later this month.
Currently, all drugs for the treatment of COVID-19 approved in the United States require injection or intravenous drip. The advantage of pills is that they are sold at the pharmacy and are taken at home.
The British Medicines and Health Products Agency approved a Merck pill known as Molnupiravir on Thursday. The European Union Medicines Regulatory Authority, the European Medicines Agency (EMA), has said it will expedite the review of the Merck tablet and is ready to make recommendations to individual EU member states so that they can make this tablet available for emergency use prior to EMA authorization.
When the Merck pill was presented for approval last month, White House Coronavirus Coordinator Jeff Zientes said the US government had already negotiated 1.7 million doses of the pill, with the option to purchase more if needed.