NANOSNET

NANOSNET,

A patient with newly diagnosed LHON asked me if instead of getting Idebenone on the internet, he should be getting it via prescription from me for Raxone.  

Is Raxone available via prescription in the US?  As far as I can tell it has not been FDA approved.

Assuming that Raxone is approved by the FDA at some point, I'd be interested to know your perspectives on whether it would be worth using the specific brand name medication?

Thank you,

Sean Gratton

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It is not FDA approved and I think (although who knows with the FDA) unlikely to receive FDA approval as it did not meet phase 3 placebo controlled RCT primary endpoints. If it is every approved, the major potential benefits would be 1) quality control due to FDA regulation, 2) cost as it may be covered by insurance. But idebenone has never met any studies primary endpoint and the current high cost calls into question the cost-benefit.

Best,

Drew

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Andrew Carey
Associate Professor
Wilmer Eye Institute, Johns Hopkins Medicine
Baltimore MD
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