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“The authorization of the first medicine, COVID-19, today is an important step in the fight against the virus,” said Stela Kiriakides, health commissioner for the European Union.
“We grant this permission less than a month after the submission of the application. This clearly shows the EU’s determination to react quickly when any treatment is available,” he added.
At least two studies in the United States have shown that remdesivir can reduce the length of hospitalization in COVID-19 patients.
Washington authorized the use of this medication for the treatment of COVID-19 as early as May 1. His example was later followed by several Asian countries, including Japan and South Korea.
The EC decision was based on a recommendation by the European Medicines Agency (EMA) on June 25 to treat remdesivir in coronavirus-infected patients 12 years of age and older who have developed pneumonia and require supplemental oxygen.
The agency said its evaluation was largely based on data from a study funded by the U.S. National Institute of Allergy and Communicable Diseases (NIAID).
The study findings, published in the prestigious New England Journal of Medicine in May, show that remdesivir injections, originally designed to treat Ebola fever, accelerated patients’ recovery compared to the placebo group alone.
Remdesivir therapy reduced the average length of hospitalization of patients from 15 to 11 days.
However, the authors of another study published in The Lancet found no “significant clinical benefit” in treating patients with remdesivir.
“After reviewing the available data, the agency concluded that the benefit-risk balance has been shown to be positive in the treatment of patients with pneumonia who require supplemental oxygen, i. “Seriously ill patients,” the Amsterdam-based EVA said in a statement in late June.
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