Washington, December 14, 2014 : .Pfizer announced Tuesday that Paxlovid’s final analysis, an antiviral medication against Covid was 89 percent effective at reducing the death or hospitalisation of high-risk patients. These findings are consistent with interim results announced last month based upon an analysis of 1,200 individuals.Final results analyzed data from 2,246 adult participants who had been enrolled before November 4.
According to the US drugmaker, recent laboratory data suggest that Paxlovid is still effective against Omicron mutants that have been hypermutated.
Each patient received either Paxlovid (or placebo) orally for the duration of the trial.
This was done every twelve hours over five days.The trial saw 12 deaths in comparison to the twelve who had received placebo.
This news confirms that Paxlovid, an oral antiviral drug candidate, can have a significant impact on many lives if it is approved or authorized.The data also support Paxlovid’s effectiveness in decreasing hospitalisations and deaths and showing a significantly lower viral load.
Albert Bourla (Chairman and Chief Executive Officer of Pfizer) said that this data demonstrates the potential for the treatment candidate to save lives around the globe.
He said that “emerging variants, such as Omicron have increased the need for access to treatment options for people who contract the virus.We are confident this potential treatment, if approved or authorized, could be a crucial tool in helping quell the pandemic.”
Pfizer released data from an early clinical trial that showed the treatment decreased hospitalisations in 600 adults at high risk.
Company expects to receive authorisation from the US Food and Drug Administration and other regulatory authorities soon for high-risk patients.
A full course of Pfizer’s treatment is three pills taken twice daily for five days.
Two of the pills are an experimental antiviral called nirmatrelvir, the third pill is an existing HIV drug called ritonavir.
Nirmatrelvir is designed to block the activity of an enzyme that the coronavirus needs to replicate.
Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus, the company said.
Nirmatrelvir has shown consistent in vitro antiviral activity against the previously identified variants of concerns (i.e., Alpha, Beta, Delta, Gamma, Lambda, and Mu).In addition, nirmatrelvir potently inhibited the enzyme associated with Omicron in an in vitro biochemical assay, the company said.
“This indicates nirmatrelvir’s potential to maintain robust antiviral activity against Omicron.Additional in vitro antiviral studies with this variant are underway,” it added.
If authorised or approved, Paxlovid will be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice daily for five days.
One box contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.
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