FDA approves first Ebola treatment

More than two years after the Democratic Republic of the Congo (DRC) began wrestling with the world’s second-largest outbreak of Ebola, the US Food and Drug Administration (FDA) yesterday approved the antibody cocktail Inmazeb for the treatment of Ebola virus.

The monoclonal antibody cocktail produced by Regeneron is a combination of atortibimab, maftibimab, and odesibimab-ebgn, all of which serve to prevent viral glycoproteins from adhering to and invading healthy cells. In a clinical trial conducted at the time of the outbreak in the North Kivu region, patients treated with Inzameb (then known as REGN-EB3) experienced a 33.5% mortality rate after 28 days. The World Health Organization (WHO) reports that virus mortality fluctuates between 25% and 90% depending on the outbreak.

“Decades of investment in us VelociSuite Rapid response technology, the dedication of world-class scientists, the courageous contributions of healthcare providers and patients, and the remarkable cooperation between major international health agencies and the government have brought about this important moment. ” Dr. D. Jancoporus, said. PhD, President and Chief Scientific Officer of Regeneron Press release..

To control the outbreak of the Ebola virus, Inmazeb is given free of charge at the DRC with the support of the Biomedical Advanced Research and Development Agency (BARDA), and Regeneron is working with non-governmental organizations and public health agencies. Make sure income countries are eligible for treatment.In addition, BARDA 6 year purchase contract To help Inzameb prepare the United States for a public health emergency.

“Today’s approval highlights the importance of international cooperation in the fight against the Ebola virus,” said John Farley, MD, director of the FDA’s Center for Drug Evaluation and Research for Infectious Diseases. Press release.. “The urgent need for advanced treatments to combat this infection is clear, and today’s actions are an important step forward in that effort.”

Four Ebola treatments were considered in the PALM trial

Inmazeb was not the only treatment tested during clinical trials. Three other candidates, mAb114, ZMapp, and remdesivir, were also considered, with day-28 mortality rates for patients receiving these drugs at 35.1%, 51.3%, and 53.1%. Each.Under all PALM (Together We Protect Life) Trial, 681 patients attended from November 20, 2018 to August 9, 2019, and 228 patients received additional doses of inmazeb. After the exam was completed, Inmazeb received priority review by the FDA.

Treatment (intravenous injection of 50 milligrams (mg) of each antibody per kilogram) was studied in pediatric and adult patients, including newborns whose mothers were infected with the Ebola virus. Researchers have warned providers not to administer a live vaccine of Ebola virus and Inzameb at the same time, but the earlier the treatment, the more effective it was.

Adverse side effects, which may have been caused by the Ebola virus itself, were found in at least 10% of patients with imazeb with common illnesses such as fever, chills, tachycardia, tachypnea, and vomiting. With the exception of the more severe chills, the side effects were comparable to the effects of Zmapp.

DRC will be case-free for 15 days and WHO will appoint experts to lead the investigation of sexual abuse

As of October 14, DRC has been 15 days old and no new cases of Ebola virus infection have been reported.Before that, one case was confirmed September 30 When September 21, Both as part of 124 outbreaks in the Democratic Republic of the Congo in Equator. While the small number of new cases is good, observers remain worried about future responses due to the COVID-19 pandemic and potentially restricted access to infected populations.

The country is currently the 11th outbreak of the Ebola virus. International aid organizations have provided assistance with millions of dollars in funding, workers, testing and treatment resources, etc., but their efforts have been contaminated with allegations of sexual abuse.Ann Investigation The New Humanitarian and Reuters announced in September that they interviewed 51 women who testified that men claiming to belong to organizations such as the WHO proposed or forced sex.

Immediately after that, WHO Said he was indignant According to reports, it will actively investigate the allegations. In today’s related development, Presentation Appointing two co-chairs to an independent committee investigating the matter. They are Aichato Mindaudu, a former Minister of Foreign Affairs and Social Development in Niger who worked for the United Nations in Côte d’Ivoire and Darfur, and the Democratic Republic of the Congo, an internationally renowned human rights activist and advocate for survivors of sexual violence. This is Julian Lucenge. Conflict settings.