Covid: Pfizer's Paxlovid soon to be marketed in the United States?

Published by Laurent P., Manon C. · Updated on 17 November 2021 at 10h20 · Published on 17 November 2021 at 09h11
On Tuesday November 16, drugmaker Pfizer announced they are seeking approval for emergency marketing for their Covid therapy, Paxlovid, to the FDA - the Food & Drug Administration. According to the latest data of a study, the medicine is 89% effective against hospitalization risks and death.

Good news amid the Covid fight to complete the therapy offer currently available. The Pfizer laboratory announced this Tuesday November 16, 2021 they are seeking emergency approval for marketing for their Covid pill, Paxlovid, to the FDA, the Food & Drug Administration.

In late September 2021, the laboratory announced they have started clinical trials in two of their locations – on in the United States, the other in Belgium – for a potential coronavirus medicine created as a pill to take as a prevention for 5 to 10 days. Called “PF 07321332”, this therapy has been given to over 2,600 volunteers aged 18+ as part of the clinical trial phases 2 and 3. This Friday November 5, 2021, Pfizer has unveiled the first results of their clinical trials and they are more than conclusive.

As a matter of fact, Pfizer announced the Covid pill is 89% effective to prevent hospitalization hazard and death. "The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset", the company stated.

Although trials are far from finished, in all 3,000 people will take part in it. But the company has already announced they are turning down extra volunteer enrollment, "due to the overwhelming efficacy" of their drug. Furthermore, the drugmaker announced they intend to release the first results "as soon as possible" to the U.S. Food and Drug Administration (FDA) for authorization and marketing approval under the name of Paxlovid.

Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer

As for this medicine, it involves a “protease inhibitor”, which is a molecule inhibiting an enzyme cutting peptide bonds of the proteins, preventing the virus from doing what it is programmed for. A genuine “custom antiviral” developed to directly aim at the “spine” of the virus and prevent it from developing in the nasal cavities, the mouth, and the lungs.

We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care", said Mikael Dolsten, chief scientific officer and president, worldwide research, development and medical of Pfizer in a release. This Tuesday September 28, they explain that in the event of conclusive trials, "we think thie therapy could help stop the virus very early on - before it can widely replicate itself - potentially preventing symptomatic cases of the disease in those who have been exposed and by preventing the infection to start in others"

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