Shiloh
Editor, Senior Moderator
Source: https://www.cidrap.umn.edu/news-perspective/2020/04/ebola-scan-apr-16-2020
Ebola Scan for Apr 16, 2020
WHO weighs in on DRC Ebola; Ebola drug fast-track review
Filed Under:
Ebola; VHF
WHO weighs in on recent DRC cases, notes vaccine supply challenges
The World Health Organization (WHO) today fleshed out more details on the three recently reported Ebola cases in the Democratic Republic of the Congo (DRC) city of Beni, noting that all are epidemiologically linked and that samples have been sent for genetic testing to see if they are part of a known transmission chain.
In its update, the WHO said two of the patients died in the community after visiting several healthcare facilities, a situation known to raise the risk of virus spread. The third patient is being treated at an Ebola treatment center.
So far, 332 contacts have been identified, and 200 have been vaccinated. Though there are about 6,000 vaccine doses in Beni, the WHO said the supply pipeline is likely challenged because of COVID-19 flight restrictions.
Other challenges are armed groups and limited access in some areas, with possible under-reporting. On Apr 9, health officials validated two probable cases in patients who were sick in November and December.
So far, the DRC has reported 3,458 cases since August 2018, of which 3,313 are lab-confirmed, with 2,277 deaths.
Apr 16 WHO statement
FDA accepts Regeneron Ebola drug for fast-track review
Regeneron announced today that the US Food and Drug Administration (FDA) has granted priority review for its monoclonal antibody cocktail drug for treating Ebola.
The drug, REGN-EB3, is a triple-antibody drug that was studied in Ebola treatment centers in the current Democratic Republic of the Congo (DCR) outbreak and was one of two drugs that stood out as more effective than other options.
In a statement today, Regeneron, based in Tarrytown, New York, said the target dates for the FDA decision is Oct 25, 2020. It said its licensing data are based on a randomized controlled study in the DRC that was stopped early in August 2019 when it showed pre-specified superiority over the control drug ZMapp. The company said it has also used the same approach to develop an antibody drug to treat COVID-19, with clinical trials expected to be begin in June.
REGN-EB3 had already received orphan drug and breakthrough designation from the FDA. The drug was developed through a collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Apr 16 Regeneron press release
Nov 27, 2019, CIDRAP News story "New data highlight promise of 2 Ebola treatments"
Ebola Scan for Apr 16, 2020
WHO weighs in on DRC Ebola; Ebola drug fast-track review
Filed Under:
Ebola; VHF
WHO weighs in on recent DRC cases, notes vaccine supply challenges
The World Health Organization (WHO) today fleshed out more details on the three recently reported Ebola cases in the Democratic Republic of the Congo (DRC) city of Beni, noting that all are epidemiologically linked and that samples have been sent for genetic testing to see if they are part of a known transmission chain.
In its update, the WHO said two of the patients died in the community after visiting several healthcare facilities, a situation known to raise the risk of virus spread. The third patient is being treated at an Ebola treatment center.
So far, 332 contacts have been identified, and 200 have been vaccinated. Though there are about 6,000 vaccine doses in Beni, the WHO said the supply pipeline is likely challenged because of COVID-19 flight restrictions.
Other challenges are armed groups and limited access in some areas, with possible under-reporting. On Apr 9, health officials validated two probable cases in patients who were sick in November and December.
So far, the DRC has reported 3,458 cases since August 2018, of which 3,313 are lab-confirmed, with 2,277 deaths.
Apr 16 WHO statement
FDA accepts Regeneron Ebola drug for fast-track review
Regeneron announced today that the US Food and Drug Administration (FDA) has granted priority review for its monoclonal antibody cocktail drug for treating Ebola.
The drug, REGN-EB3, is a triple-antibody drug that was studied in Ebola treatment centers in the current Democratic Republic of the Congo (DCR) outbreak and was one of two drugs that stood out as more effective than other options.
In a statement today, Regeneron, based in Tarrytown, New York, said the target dates for the FDA decision is Oct 25, 2020. It said its licensing data are based on a randomized controlled study in the DRC that was stopped early in August 2019 when it showed pre-specified superiority over the control drug ZMapp. The company said it has also used the same approach to develop an antibody drug to treat COVID-19, with clinical trials expected to be begin in June.
REGN-EB3 had already received orphan drug and breakthrough designation from the FDA. The drug was developed through a collaboration with the Biomedical Advanced Research and Development Authority (BARDA).
Apr 16 Regeneron press release
Nov 27, 2019, CIDRAP News story "New data highlight promise of 2 Ebola treatments"