The European Medicines Agency (EMA) has given conditional approval for the distribution of the pill called “Paxlovid”, developed by the US-based company Pfizer, against coronavirus, for use in severe patients within the borders of the European Union (EU).
The drug is said to reduce death rates and hospitalizations among Covid patients at serious risk.
In December, EMA granted emergency use permission to the Covid pill, which was approved by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Agency (MHRA).
Conditional approval for any drug means that patients are approved for unmet medical needs based on less extensive data than is normally required.
The European Medicines Agency, headquartered in Amsterdam, approved the drug Paxlovid for use in severe coronavirus patients across Europe on Thursday.
The drug, developed by Pfizer, is used in adults who test positive for coronavirus and are in a certain risk group, such as cancer, diabetes or obesity.
5 days of treatment in the first 5 days
The drug is given to Covid harvesters in the risk group who cannot receive extra oxygen, within 5 days after the first symptoms appear.
According to research conducted on more than 2,000 people with chronic diseases, the pill called Paxlovid reduces the risk of hospitalization or death due to Covid in people at serious risk.
The drug is aimed at helping patients treat at home. At-risk Covid patients are advised to take 30 pills for 5 days. Patients take three Paxlovids 2 times a day.
The drug consists of 2 separate pills. Patients take pills containing 2 “Nirmetrelvir” and 1 “Ritonavir” each time.
According to research submitted to the EMA, 0.8 percent of patients given Paxlovid stayed in the hospital for at least 24 hours. None of the patients in this group died. 6.3 percent of patients who received an ineffective solution known as a placebo stayed in the hospital for at least 24 hours, and 9 of them died.
According to Ton de Boer, head of the Dutch Drug Evaluation Board (MEB), the Covid drug has mild side effects such as short-term taste change, headache, vomiting and a temporary increase in blood pressure.
The main problem with the pill is that it interacts with other drugs, making them stronger or less effective.
De Boer stated that the effect of the drug was examined on the Delta variant of the coronavirus, and said that its effectiveness against the Omicron variant was also detected in the laboratory, but this has not yet been fully investigated in practice.
De Boer emphasized that the drug does not prevent catching Covid, but only helps with existing vaccines and treatments.
After the final approval of the EU Commission, the distribution of the drug Paxlovid will begin across Europe.