we are talking about the drug “Ramdevpir”, which was used for the treatment of Ebola. In Russia, this drug is undergoing clinical trials.
the European medicines Agency (EMA) recommended granting a conditional permit to sell the drug Veklury (Remdesivir, “Ramdevpir”) that can be used to treat adults and adolescents 12 years and older with a diagnosis of “pneumonia” and positive tests for coronavirus COVID-19. It is reported press service Agency.
“”Ramdevpir” is the first drug against COVID-19 recommended for authorization in the EU”, — stated in the message.
Conditional permission for sale is one of the regulatory mechanisms of the European Union to facilitate early access to medicines, covering unmet medical needs, including in emergencies, such as pandemic coronavirus COVID-19.
This is done if the benefit of immediate availability for cases greater than the risk associated with the fact that not all data are available.
the Agency said that the EMA Committee on medicinal products for human use (CHMP) began evaluating data on the quality and production of “Ramdevpir” from April 30, long before the submission by the manufacturer of the application for a permit for sale (5 June).
the Final decision on granting conditional permission, according to the report, was mainly taken on the basis of studies sponsored by the us National Institute of allergic and infectious diseases (NIAID) and several other studies. NIAID evaluated the efficacy of 10-day course of “Ramdevpir” more than 1 thousand hospitalized patients with COVID-19. “Overall, the study showed that patients who received “Ramdevpir” recovered in approximately 11 days compared with 15 days among patients receiving placebo,” — said the Agency.
The EMA said that the use of “Ramdevpir” there is a limitation — it can only be applied in the medical institutions with inpatient regime. The drug is used by injecting into a vein. “Treatment should begin with infusion of 200 mg on the first day, after which is injected daily at 100 mg for at least four days and not more than nine days,” — said the Agency.
In mid-April, canadian researchers stated that “Ramdevpir”, which was used for the treatment of Ebola, blocks the replication of the coronavirus. They tested the drug for the treatment of middle East respiratory syndrome (MERS) and SARS SARS-COV similar to the RNA structure with the current coronavirus infection SARS-CoV-2.
the Researchers said that the results of the tests of the drug against them was great��virtually identical.
In early may, the management on sanitary inspection behind quality of foodstuff and medicines (FDA) has granted emergency permission to use the “Ramdevpir” in the United States for the treatment of infected with a coronavirus. A few days before that, the head of NIAID, Anthony Fauci, spoke about the successful clinical trials of “Ramdevpir”.
In March, the health Ministry of Russia stated that “Ramdevpir” is on the list of drugs that are under clinical trials in patients with COVID-19. Then, the office noted that reliable data about the effectiveness of this medication is not available.