Health
FDA approves first Ebola virus treatment
The US Food and Drug Administration (FDA) has approved atortibimab, maftibimab, and odesibimab-ebgn (inmazeb) for the treatment of adult and pediatric patients. Zaire Ebola virus (Ebola virus) infection.
This indication makes Regeneron Pharmaceuticals’ monoclonal antibody cocktail the first drug approved for the treatment of Ebola virus.
Triple therapy is designed to target glycoproteins on the surface of the virus, block its attachment to cell receptors, and prevent the virus from entering cells.
Its effectiveness and safety are 382 adults and 382 adults led by the National Institutes of Health (NIH) and the DRC’s National Institutes of Health (Institut National de Recherche Biomédicale) as part of an extended access program implemented in the Democratic Republic of the Congo. It was observed in the PALM trial, which is an evaluation of pediatric patients. Congo (DRC) at the time of the 2018-2019 outbreak.
A multicenter, open-label, randomized controlled trial compared 154 patients who received 50 mg of each Inmazeb monoclonal antibody intravenously in a single infusion with 168 patients who received control therapy during the trial. Did. The primary efficacy endpoint was 28-day mortality.
One-third (33.8%) of patients treated with inmazeb died after 28 days, compared to 51% of control patients. The researchers provided treatment to another 228 patients with an extended access program.
The most common symptoms reported among treated patients included fever, chills, tachycardia, tachypnea, and vomiting. These symptoms are also closely associated with Ebola virus infection. Patients receiving imazeb have been advised by the FDA to avoid co-administration of live vaccines due to their therapeutic ability to inhibit live vaccine virus replication and reduce its effectiveness.
Previously approved by the FDA The first vaccine to prevent Ebola virus disease in December 2019.
Ebola virus is commonly known for its series of international outbreaks over the last few decades and is transmitted by direct contact with the blood, body fluids, tissues, and contaminated surfaces and substances of infected people and wildlife. I will. Care providers who are infected with the virus, especially those who do not have proper personal protective equipment (PPE), are often at greatest risk of infection.
FDA Commissioner Stephen M. Hahn, MD, called this decision a demonstration of the authorities’ ongoing commitment to responding to “science and data-based” public health threats.
“This approval is made possible thanks to our firm dedication to facilitating the development of safe and effective treatments for infectious diseases as part of our important public health mission.” He said. statement.
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