Based in Burbank, California, Robert Gadimian focuses on pharmaceutical regulatory affairs as president of Perceptive Regulatory Consulting. Robert Gadimian helps manage all aspects of the new drug development process under health authority regimens such as the US Food and Drug Administration (FDA).
The FDA was recently in the news with the approval of the first ever successful treatment for the Ebola virus, which stands as one of the deadliest pathogens to humankind. The virus has a mortality rate of as much as 90 percent among those who contract it and are not treated. The new drug was developed through a public-private partnership between the Biomedical Advanced Research and Development Authority in Congo and the US pharmaceutical firm Regeneron.
Inmazeb, which combines three monoclonal antibodies, was tested in a Congo clinical trial involving 382 pediatric and adult patients. The mortality rate among Ebola patients who received Inmazeb was approximately one-third, as opposed to more than 50 percent among those who did not receive the drug.
Inmazeb has been developed to address the Zaire strain of Ebola, which is the virus’ most common and deadliest form. Initially identified in 1976, it was responsible for 11,300 deaths during a major 2014-15 outbreak. Underlining the continued importance of the therapeutic, in 2020 a smaller outbreak emerged that had killed 100 Congolese by mid-September.
The FDA was recently in the news with the approval of the first ever successful treatment for the Ebola virus, which stands as one of the deadliest pathogens to humankind. The virus has a mortality rate of as much as 90 percent among those who contract it and are not treated. The new drug was developed through a public-private partnership between the Biomedical Advanced Research and Development Authority in Congo and the US pharmaceutical firm Regeneron.
Inmazeb, which combines three monoclonal antibodies, was tested in a Congo clinical trial involving 382 pediatric and adult patients. The mortality rate among Ebola patients who received Inmazeb was approximately one-third, as opposed to more than 50 percent among those who did not receive the drug.
Inmazeb has been developed to address the Zaire strain of Ebola, which is the virus’ most common and deadliest form. Initially identified in 1976, it was responsible for 11,300 deaths during a major 2014-15 outbreak. Underlining the continued importance of the therapeutic, in 2020 a smaller outbreak emerged that had killed 100 Congolese by mid-September.
