The European medicines Agency (EMA) recommended conditional approval on sale anti – virus product ramdevpir as a drug for the treatment of COVID-19.
As reported by EP, the corresponding statement posted on the Agency’s website.
“The EMA Committee for medicinal products for human use (CHMP) recommended granting Veklury (ramdevpir) conditional marketing authorization for the treatment COVID-19 in adults and adolescents from 12 years of age with pneumonia who need supplemental oxygen,” – said in a statement.
Ramdevpir is the first drug against COVID-19 recommended for authorization in the EU.
It is noted that the data on ramdevpir was evaluated in a very short time with the help of the approach used by EMA during emergency situations in public health to assess the data as it is received.
The assessment ended with recommendations that are mainly based on survey data NIAID-ACTT-11 sponsored by the National Institute of Allergy and infectious diseases of the United States, as well as on data of other studies on ramdevpir.
The study evaluated the effectiveness of the planned 10-day course of ramdevpir at more than 1,000 hospitalized patients with COVID-19. Ramdevpir compared with placebo (a dummy treatment), and the main indicator of effectiveness was the patient’s recovery time.
Overall, the study showed that patients who received ramdevpir recovered in approximately 11 days compared with 15 days among patients receiving placebo. This effect was not observed in patients with mild and moderate course of the disease: time to recovery was 5 days for both group of ramdevpir, and for the placebo group.
For patients with severe disease constitute approximately 90% of the study group, time to recovery was 12 days in a group of ramdevpir and 18 days in the placebo group.
However, during the recovery was not observed any difference in patients who started taking ramdevpir when they were already on a ventilator or ecmo (extracorporeal membrane oxygenation).
“Taking into account the available data, the Agency believes that the risks and benefits was positive in patients with pneumonia who need supplemental oxygen, and patients with severe diseases,” – said in a statement.
It is noted that ramdevpir drip inserted into a vein, and its use is limited to medical institutions where patients can be closely observed. Before and during treatment should monitor liver and kidneys. Treatment should begin with infusion of 200 mg on the first day, then introduced one infusion of 100 mg per day for at least 4 days and no more than 9 days.
“The European Commission, which received information from the EMA during the evaluation process, accelerate the decision-making process and intends to provide a decision about the conditional authorization of the sale of ramdevpir in the next week that will allow you to sell the product in the EU,” reads the statement.