For immediate release:

Today, the US Food and Drug Administration has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment. Zaire Ebola virus (Ebola virus) Infection in adult and pediatric patients.

“Today’s actions demonstrate the FDA’s ongoing commitment to addressing national and international public health threats based on science and data,” said FDA Doctor of Medicine Stephen M. Hahn. “This approval is made possible thanks to our firm dedication. As part of our important public health mission, we facilitate the development of safe and effective treatments for infectious diseases.”

Zaire Ebola virusOne of four, commonly known as the Ebola virus Ebola virus A species that can cause potentially deadly human illness. Ebola virus is transmitted by direct contact with the blood, body fluids, tissues of infected people and wildlife, and surfaces and materials such as bedding and clothing contaminated with these fluids. Individuals who provide care for people infected with the Ebola virus, including health care workers who do not take proper infection control precautions, are at greatest risk of infection.

Inmazeb targets glycoproteins on the surface of the Ebola virus. Glycoproteins attach to cell receptors and fuse the virus with the host cell membrane, allowing the virus to invade cells. The three antibodies that make up imazeb can simultaneously bind to this glycoprotein and block the attachment and invasion of the virus.

Inmazeb was evaluated in 382 confirmed adult and pediatric patients Zaire Ebola virus Infection as part of one clinical trial (PALM trial) and an extended access program conducted in the Democratic Republic of the Congo (DRC) during the 2018-2019 outbreak of the Ebola virus. The PALM study was led by the National Institutes of Health in the United States and the National Institutes of Health in the Democratic Republic of the Congo, with contributions from several other international organizations and institutions.

“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. “The urgent need for advanced treatments to combat this infection is clear, and today’s actions are an important step forward in that effort.”

In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a multicenter, open-label, randomized controlled trial in which 154 patients received Inmazeb (50 mg of each monoclonal antibody) intravenously as a single infusion. .. Received clinical trial management. The primary efficacy endpoint was 28-day mortality. The primary analysis population was all patients who were randomized and at the same time eligible to receive either imazeb or study control during the same period of study. Of the 154 patients who received Inmazeb, 33.8% died after 28 days, compared with 51% of the 153 patients who received the control. In the Compassionated Access program, an additional 228 patients received Inmazeb.

The most common symptoms experienced during administration of Inmazeb include fever, chills, tachycardia (fast heart rate), tachypnea (fast breathing), and vomiting. However, these are also common symptoms of Ebola virus infection. Patients receiving imazeb should avoid co-administration of live vaccines as they may block the replication of the live vaccine virus, which is indicated for the prevention of Ebola virus infection, and reduce the effectiveness of the vaccine.

Hypersensitivity, including infusion-related events, can occur in patients taking Inmazeb and treatment should be discontinued in the case of hypersensitivity reactions.

Inmazeb Designation of orphan drugs For the treatment of Ebola virus infection. Orphan drug designation provides an incentive to support and encourage drug development for rare diseases.In addition, the agency is in Inmazeb Designation of breakthrough therapy For the treatment of Zaire Ebola virus infection.

The FDA has given approval to Regeneron Pharmaceuticals.

FDA Approved Elbebo, the first vaccine to prevent Ebola disease, was conducted in December 2019 with the support of a study conducted in Guinea during the 2014-2016 outbreak of Ebola.

The FDA, an agency within the U.S. Department of Health and Human Services, by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other human biological products, and medical devices. Protects public health. The agency is also responsible for the safety and security of our food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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