Good news amid the Covid fight to complete the therapy offer currently available. This Monday January 10, 2022, the European Medicines Agency announced they have received application for conditional marketing authorization for a Covid-19 preventive therapy by the Pfizer laboratory, Paxlovid. The therapy is expected to arrive in France by the end of late January, although the Haute Autorité de Santé has not approved it yet.
The therapy which clinical trials have been studied prior to the process by the EMA. It will be subject to assessment under a "reduced timeline". Paxlovid could be marketed "within weeks" if "data submitted are sufficiently robust", the European regulator explains in a release.
This past December 14, Pfizer already confirmed in a study their preveventive therapy, Paxlovid, is 89% effective against severe coronavirus. According to the study involving 2,246 volunteers, the therapy is more effective when given three days after the onset of symptoms.
"This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load", said Albert Bourla, Chariman and Chief Executive Officer, Pfizer. He goes on: "This underscores the treatment candidate’s potential to save the lives of patients around the world".
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. “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, in a release.
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"
As for marketing, this past November 16, the FDA claimed they have filed emergency approval, as reported by Nouvel Obs. More to come from the European Medicines Agency, then.