Pfizer, one of the world’s largest pharmaceutical companies, known for the coronavirus vaccine it has 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 Union’s drug regulator, the European Medicines Agency (EMA), announced in its announcement that the antiviral drug called ‘Paxlovid’ developed by Pfizer is recommended to receive conditional market approval. With this approval, Paxlovid will be the first approved drug for oral use in the treatment of COVID-19 in the EU.
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 noted that the drug can be used in adult patients who “do not need oxygen therapy and are at risk for the disease to become severe”. 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 can cause mild side effects such as short-term taste changes, headache, vomiting and a temporary increase in blood pressure. Paxlovid drug consists of two different pills containing PF-07321332 and ritonavir.
With this green light, the European Commission will speed up the decision process to make a decision on conditional market authorization for Paxlovid, eventually allowing this drug 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.
37842
