- The authorization will include mild and moderate, adult, and pediatric patients after being inclusive of severe cases.
- According to recent studies, the drug reduces the mortality rate to less than 2%, accelerates recovery, and shortens hospitalization time.
- Dr. Hossam Hossny: “The results of using Remdesivir in Egypt match the global results; I expect the World Health Organization to broaden the sphere of Remdesivir use furthermore.”
Cairo, September 1, 2020 – “EVA Pharma’s Remdesivir achieves positive global results and we are equipped to cooperate with many authorities to provide all needed quantities in Egypt and more than 100 countries” Dr. Riad Armanious, CEO.
Remdesivir granted broader authorization by the American Food and Drug Administration upon recent clinical studies which show its effect on accelerating COVID-19 patients’ recovery, not only in severe cases but also in mild and moderate conditions. Now the emergency use authorization includes use for adults and pediatrics alike regardless of the severity of their symptoms.
The initial issuance of the (EUA) of Remdesivir by the FDA, which was also adopted by other countries with access to the drug, was limited to patients with severe disease, which was defined as patients with low oxygen levels or need oxygen therapy or more intensive breathing support as a mechanical ventilator.
In its recent report, the FDA stated that the known potential benefits of Remdesivir outweigh its risks. Thus, the broader use authorization of the antiviral is based on a clinical trial conducted by the U.S. National Institute of Allergy and Infectious Diseases investigating 1062 hospitalized COVID-19 patients. The study showed the median time to recovery was 10 days for the Remdesivir group compared to 15 days for the placebo group. Other clinical trials have revealed a reduced mortality rate to less than 2% when patients are treated with Remdesivir.
It is important to note that the new authorization restricts the use of Remdesivir under medical supervision and only for hospitalized patients.
“The results of Remdesivir use in Egypt match the global results” confirmed Dr. Hossam Hossny, head of the Anti-Coronavirus Scientific Committee at the Ministry of Health and Population in a scientific conference attended by Minister of Health Dr. Hala Zayed, and presidential advisor for health affairs, Dr. Mohamed Awad Tag El-Den. Hosny anticipated that WHO broadens the indication of Remdesivir use in the future based on its benefits to mild and moderate conditions.
Egypt is one of the first countries to benefit from the use of Remdesivir after the licensing agreement between Gilead Sciences and EVA Pharma, allowing the company to be one of the first 3 facilities to manufacture the drug worldwide.
Following the FDA report and clinical studies, Dr. Riad Armanious, EVA Pharma CEO, emphasized his company’s keenness to provide Egypt and more than 100 countries with their needs of Remdesivir-EVA Pharma®.
In his statement, Armanious said the global results of using Remdesivir-EVA Pharma® corresponds to the positive results of the aforementioned clinical studies. Affirming the drug’s effect in accelerating recovery time and reducing the need for mechanical ventilation and hospital care.
EVA Pharma’s CEO shared his company’s pride to be one of the first three facilities in the world to have worked on Remdesivir manufacturing, covering the Egyptian need of the drug to treat severe cases as well as the needs of a number of countries around the globe.
Armanious assured that EVA Pharma is equipped to cooperate with all the Egyptian governmental health authorities to provide all needed quantities of COVID-19 treatments and other medicines.
A new Antiviral drug developed by Gilead Company and produced by EVA Pharma in Egypt. Remdesivir got an FDA license for exceptional use (Emergency Use Authorization) for treating new COVID-19 patients in hospitals in the United States and the United Kingdom & now it got the FDA Broadens Emergency Use Authorization including mild and moderate, adult and pediatric COVID-19 patients. It has also been approved by the European Medicines Agency “EMA” for use in severe and critical COVID-19 cases and it’s already used in many European countries. It also obtained full approval for official use in Japan for critical cases.