US-based Pfizer has announced the final results of its novel COVID-19 antiviral oral pill named PAXLOVID. Pfizer analysed the effects of this pill on 2,246 adults enrolled its phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk patients). PAXLOVID reduced the risk of hospitalisation or death for any cause by around 89 per cent compared to placebo in patients treated within 5 days of onset of symptoms. The EPIC-HR trials data has been shared with US Food and Drug Administration (FDA) as part of a rolling submission for Emergency Use Authorisation (EUA).
According to Pfizer’s press release, the data further stated that 0.7 per cent of patients who got PAXLOVID were hospitalised with no deaths through Day 28 following randomisation -- 5/697 compared to 6.5 per cent of patients who were administered the placebo and were hospitalised or died—44/682 hospitalised with 9 subsequent deaths. The release further states that PAXLOVID reduced the risk of hospitalisation and/or death in patients above 65 years or old by 94 percent.
It explains that 1.1 percent of patients who received PAXLOVID were hospitalised through Day 28 (1/94 hospitalised with no deaths) compared to 16.3 percent of patients who received the placebo (16/98 hospitalised with 6 deaths.
“Treatment-emergent adverse events were comparable between PAXLOVID (23 per cent) and placebo (24 per cent) most of which were mild in intensity. Fewer serious adverse events (1.6 per cent vs 6.6 per cent) and discontinuation of study drug due to adverse events (2.1 per cent vs 4.2 per cent) were observed in patients dosed with PAXLOVID, compared to placebo, respectively,” Pfizer noted.
“This news provides further corroboration that our oral antiviral candidate, if authorised or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of PAXLOVID in reducing hospitalisation and death and show a substantial decrease in virus load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” Pfizer Chairman and CEO Albert Bourla said.
He added, “Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorised or approved, this potential treatment could be a critical tool to help quell the pandemic.”
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