The European Medicines Agency (EMA) announced that Pfizer has given approval for the use in the EU of the oral COVID-19 drug, which was previously authorized for emergency use in the USA. The drug will begin to be distributed to all EU countries with conditional marketing authorization.
Today, Pfizer, one of the largest pharmaceutical companies in the world known for its coronavirus vaccine developed jointly with BioNTech, has come to the fore again with very important news. The company, which developed a drug in pill form against COVID-19, managed to get the green light from the European Union’s drug regulator after the United States.
The European Medicines Agency (EMA), the European Union’s drug regulator, announced that the antiviral drug ‘Paxlovid’ developed by Pfizer conditional market approval is recommended. announced. With this approval, Paxlovid will be used in the EU for the treatment of COVID-19. It will be the first approved drug.
It can be used in patients who do not need oxygen therapy.
The Paxlovid application made by Pfizer to the EMA was for the treatment of patients over 12 years of age with the drug. However, the EMA states that the drug’s ‘those who do not need oxygen therapy and who are at risk for the disease to become severeHe noted that it can be used in adult patients. It was stated that the drug acts against the delta variant of COVID-19, and is expected to be effective against Omicron and other variants.
The drug, which received emergency use approval from the US Food and Drug Administration last December, provides 88% success in preventing hospitalization and death, according to Pfizer’s statements. According to the statements of Ton de Boer, Chairman of the Dutch Drug Evaluation Board, the drug is mild side effects such as short-term taste change, headache, vomiting and transient increase in blood pressure. can cause. Paxlovid drug consists of two different pills containing PF-07321332 and ritonavir.
RELATED NEWS
Pfizer and BioNTech Begin Trials for Omicron Custom Coronavirus Vaccine
With this green light, the European Commission will expedite the decision process to make a decision on the conditional market authorization for Paxlovid, and eventually this drug will allow it to be marketed throughout the EU. Once approval is granted, companies will submit more data, up to predefined deadlines, to confirm that the drug’s benefits continue to outweigh the risks.
Source :
https://www.ema.europa.eu/en/news/covid-19-ema-recommends-conditional-marketing-authorisation-paxlovid