The European Medicines Agency (EMA) today approved drugmaker Pfizer's Covid-19 tablet, which became the first antiviral for treating the disease with authorization for use in Europe.

According to a news site at the minute, which quotes a statement that "the agency has reportedly granted a conditional marketing authorization" for the drug Paxlovid, recommended for the treatment of covi-19 in "adults who do not require supplemental oxygen and who are at risk for severe disease."

Pfizer's antiviral tablet is thus the first with authorization for use in Europe.

The EMA reports that studies show that the pill "significantly reduced hospitalizations or even death in patients with at least one comorbidity that puts them at risk of developing severe disease."

In the investigations, the pill was administered five days after the onset of Covid-19 symptoms. After one month, 0.8% (eight out of 1.039) of the patients on Paxlovid treatment were hospitalized for more than 24 hours, in contrast to 6.3% (66 out of 1.046) in the control group. In addition, while the Paxlovid group recorded no fatalities, the control group reported nine deaths.

Paxlovid is also expected to act effectively against Omicron and other SARS-CoV-2 variants.

The drug was considered to be safe, "with mild side effects". Still, the agency points out that the active substance ritonavir is known to affect the action of other treatments, data that were included in the package insert.

With conditional authorization from the EMA, a 'fast-track' for the marketing process in a public health emergency such as this, the decision to place Paxlovid on the market now lies with the European Commission (EC).

However, conditional authorization "ensures that the approved drug meets the European Union's strict standards for efficacy, safety and quality, and is produced in quality facilities," the EMA assures.

Source NM