It is all about a new medicine "Remdesivir", which was used to treat Ebola. In Russia, this medicine is undergoing clinical trials.
The European Medicines Agency (EMA) recommended granting conditional approval for the sale of Veklury (Remdesivir, Remdesivir), which can be used to treat adults and adolescents over 12 years old with a diagnosis of pneumonia and positive COVID-19 coronavirus tests. This was reported by the press service of the agency.
Remdesivir is the first anti-COVID-19 drug recommended for EU approval, ”the report said.
Conditional sales authorization is one of the EU regulatory mechanisms to facilitate early access to medicines that meet unmet medical needs, including in emergency situations, such as the COVID-19 coronavirus pandemic. This type of approval allows EMA to recommend the drug for sale authorization, even if there is less evidence of its effect than is usually required. This is done if the benefit of its immediate availability to patients exceeds the risk associated with the fact that not all data on it is available.
The agency said that the EMA Committee on Human Medicines began evaluating the quality and production data of Remdesivir on April 30, long before the manufacturer submitted an application for a sale permit (June 5).
The final decision to grant conditional permission, the report said, was mainly made on the basis of a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), as well as several other studies. NIAID evaluated the effectiveness of the ten-day course of Remdesivir in more than 1,000 hospitalized patients with COVID-19. “In general, the study showed that patients receiving Remdesivir recovered after about 11 days, compared with 15 days for patients receiving placebo,” the agency said.
The EMA reported that there is a restriction on the use of Remdesivir: it can only be used in medical institutions with a stationary regime. The drug is administered by injection into a vein. “Treatment should begin with 200 mg infusion on the first day, after which 100 mg is administered daily for at least four days and no more than nine days,” the agency said.
In mid-April, Canadian scientists said that Remdesivir, which was used to treat Ebola, blocks the growth of coronavirus. They tested a drug for the treatment of Middle East Respiratory Syndrome (MERS) and SARS-CoV SARS, similar in structure to RNA with the current SARS-CoV-2 coronavirus infection. Researchers reported that the test results of the drug in relation to them were almost identical.
In early May, the Food and Drug Administration (FDA) issued an emergency permit to use Remdesivir in the United States to treat coronavirus infected people. A few days earlier, NIAID head Anthony Fauci talked about successful clinical trials of Remdesivir.
In March, the Russian Ministry of Health announced that Remdesivir is on the list of drugs that are in clinical trials in patients with COVID-19. Then, the department noted that there is no reliable data on the effectiveness of this medicine.
