FDA ENABLES USE OF INVESTIGATIONAL THERAPEUTIC IN EBOLA-INFECTED PATIENTS
After receiving a Fast-Track designation from the FDA last March for the development of an anti-Ebola viral therapeutic, Tekmira Pharmaceuticals Corporation (a Canadian leading developer of RNA interference therapeutics) announced on August 7 that the U.S. Food & Drug Administration has confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug application to a partial clinical hold. This would enable the potential use of TKM-Ebola in individuals infected with Ebola virus.
Ebola virus disease (EVD), formerly known as Ebola hemorrhagic fever, is a severe, often fatal illness in humans. Ebola outbreaks have a case fatality rate of up to 90%. The virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. In the light of the recent developments associated with the latest outbreak that involves the virus transmission in Guinea, Liberia, Nigeria and Sierra Leone, the World Health Organization (WHO) released a statement on August 8 informing that the conditions for a Public Health Emergency of International Concern (PHEIC) have been met.
No licensed vaccine neither a specific treatment are currently available, hence the importance of finding an effective drug that could be used to treat this serious and devastating illness.
Sources: WHO (World Health organization) – http://who.int
Bloomberg – http://www.bloomberg.com