Comments: This is not a Urology Update.
The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
In the PALM trial, the safety and efficacy of Inmazeb was evaluated in a multi-center, open-label, randomized controlled trial, in which 154 patients received Inmazeb (50 mg of each monoclonal antibody) intravenously as a single infusion, and 168 patients received an investigational control. The primary efficacy endpoint was 28-day mortality. The primary analysis population was all patients who were randomized and concurrently eligible to receive either Inmazeb or the investigational control during the same time period of the trial. Of the 154 patients who received Inmazeb, 33.8% died after 28 days, compared to 51% of the 153 patients who received a control. In the expanded access program, an additional 228 patients received Inmazeb.
Dr Rajeentheran Suntheralingam
Consultant Urologist / Urological Surgeon
See the following link
Breaking|1,183 views|Oct 14, 2020,10:13pm EDT
World’s First Ebola Treatment Approved By FDA
Daniel CassadyForbes StaffBusinessI cover breaking news.
The U.S. Food and Drug Administration announced approval Wednesday of the world’s first successful treatment for the Ebola virus, one of the deadliest pathogens on the planet.
Key Facts
The drug, Inmazeb, is a mixture of three monoclonal antibodies produced by U.S. pharmaceutical company Regeneron.
Inmazeb was approved for both adults and children after a trial among 382 adult and pediatric patients in the Democratic Republic of the Congo, which recently declared its 11th Ebola outbreak in just over 40 years, according to Doctors Without Borders.
While the approval does mark a significant breakthrough, Ebola is still extremely life-threatening – just over 33% of patients in the trial who were given Inmazeb died after 28 days, compared to 51% who were given a control, according to the FDA.
Inmazeb was funded by a joint partnership between Regeneron and the Biomedical Advanced Research and Development Authority while The National Institutes of Health and Congo’s Health Ministry helped administer the study, according to The Hill.
Key Background
The last major Ebola outbreak in the DRC was in August, 2018. Some 3,470 people were infected and; 2,287 were killed. It was the country’s largest-ever Ebola outbreak, and is also the second-biggest Ebola epidemic ever recorded. The largest outbreak recorded was the 2014-2016 epidemic in West Africa, which saw 28,652 and 11,325 deaths spread across 10 countries, including 11 cases and one casualty in the United States, according to the Centers for Disease Control. Ebola is transmitted through direct contact with blood, bodily fluids, and tissues of infected people or contaminated surfaces making those who live in third world countries and healthcare workers extremely high-risk for infection. The FDA approved Ervebo, a vaccine for Ebola, in 2019.
