FDA Greenlights Use of TKM-EBOLA in Current Outbreak
Thursday, August 7, 2014
Canadian drug developer Tekmira just disclosed that the FDA verbally notified them that it would partially lift the clinical hold it had placed on TKM-EBOLA a month ago. The clinical hold had been instituted as the result of cytokine elevations that had been observed in a healthy volunteer study of the drug.
By partially lifting the clinical hold, the FDA ‘blesses’ the use of TKM-EBOLA in actually infected patients whose odds otherwise would be to die from the infection. Since the FDA only has authority over health matters in the US, this is strictly only of relevance for the use in people infected with Ebola either brought back from Africa for treatment just as the two US aid workers, or in case the virus started to crop up in the US.
I am, however, inclined to interpret the news that the FDA is encouraging Tekmira to consider the use of TKM-EBOLA in Western Africa at the epicenter of the epidemic. You could imagine that if anything went wrong with the use of TKM-EBOLA, it might have had adverse consequences for the future clinical development of the drug candidate in the US.
Overall, I am pleased with this development as the clinical hold in light of the current health emergency was just unbearable. How to handle the practicalities of using TKM-EBOLA in the field, including who will bear the costs, we will have to see. Remember, financially, it is Tekmira's HBV candidate that has priority over TKM-EBOLA and so I expect TKM-EBOLA to be part of a broader effort funded by the public health bodies.
Posted by Dirk Haussecker at Thursday, August 07, 2014 
rnaitherapeutics.blogspot.ca |
