The EMA Committee for Human Medicines (CHMP) has recommended granting a conditional marketing authorization for Pfizer’s oral antiviral drug Paxlovid (PF-07321332 / ritonavir) for the treatment of COVID-19. The company had announced that it is close to 90% effective against the risk of developing severe COVID. A few days ago, President Pedro Sánchez announced that Spain has acquired 344,000 doses of this treatment in pill form, which initially will be destined for the population with the highest risk of complications.
The Committee recommends authorizing Paxlovid for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. Paxlovid thus becomes the first orally administered antiviral drug recommended in the EU to treat COVID-19 (although the final decision of the European Commission is pending).
Paxlovid contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body, while ritonavir prolongs the action of PF-07321332, allowing it to stay in the body longer. body to levels that affect the multiplication of the virus.
In reaching its conclusion, the CHMP looked at data from a study involving COVID-19 patients that showed Paxlovid treatment significantly reduced hospitalizations or deaths in patients who had at least one underlying condition that put them at risk. of suffering from severe COVID-19. The analysis was performed on patients who received Paxlovid or placebo (dummy treatment) within 5 days of the onset of COVID-19 symptoms and who did not receive, nor were expected to receive, antibody treatment. During the month following treatment, 0.8% (8/1,039) of patients who received Paxlovid were hospitalized for more than 24 hours, compared to 6.3% (66/1,046) of those who received placebo. There were no deaths in the Paxlovid group and 9 deaths in the placebo group.
Safe and useful antiviral against variables
Most of the patients in the study were infected with the delta variant. Based on laboratory studies, Paxlovid is also expected to be active against omicron and other variants.
Paxlovid’s safety profile was favorable and side effects were generally mild. However, ritonavir is known to affect the action of many other medications, and warnings and advice have been included in the Paxlovid product information. Additionally, the company has provided a drug interaction tool on its website that can be accessed via a QR code included in the product information and on the outer box.
The CHMP concluded that the medicine’s benefits outweigh its risks for the approved use and will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States.
Source: EMA
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