Saturday, November 5, 2016

FDA cracking down on compassionate-use cases for experimental Polio drug

Pocapavir is a new drug being developed to help with Polio eradication. Currently the modified polio virus contained in the vaccine can be shed from people with immune deficiency. Thus there are fears that the modified polio virus will be shed from an inoculated person and enter the environment and mutate into an infectious strain that the vaccine cannot provide immunity for. The drug Pocapavir hopes to prevent this possibility by utilizing a protease inhibitor to stop viral replication in the cell and a capsid inhibitor to prevent viral capsid formation. This drug is currently under phase 2 clinical trials for this specific application. But the even more interesting possibility is that this drug can be a therapeutic for a virus that has not even been identified yet. Acute flaccid myelitis (AFM) is a disease that causes polio like symptoms in a person but unfortunately the cause of the disease has not been conclusively identified. Many researchers have a hunch that it is caused by an enterovirus which is in the same family as polio, picornaviridae. Thus is 2014 the FDA allowed the usage of Pocapavir as a treatment to children in Colorado where an outbreak of AFM occurred, under a compassionate-use basis even while the cause of the disease was unclear. Benjamin Greenberg, a neurologist who has worked with the drug stated that the drug had a relatively weak but measurable impact on the viral replication. While there has been a growth of cases of AFM in the US the FDA is no longer allowing the company to offer the drug under the compassionate-use basis as they are now requiring the company to apply for a New Drug Application for its usage as a AFM therapeutic. With growing concern of AFM and one death linked to the disease occurring last Sunday it will be interesting to see if the FDA continues to be stern with the testing of pocapavir in a compassionate usage basis.

-Vander Harris


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