Replies to post #279357 on Anavex Life Sciences Corp (AVXL)

[bas2020]

Great question!

[Doc328]

do you plan on administering injections of Biogen's Aducanumab to your Alzheimer patients? If so, how will you monitor for possible brain swelling and micro-hemorrhaging?

I see mostly MS but still see some Alzheimer's disease patients. I am planning on offering aducanumab to patients with mild cognitive impairment and Alzheimer's disease who are healthy and understand the risks and benefits. A couple of my partners who see much more Alzheimer's disease have similar plans. I have discussed the drug with only 2 patients. Both patients who are very educated were potentially interested and understand the risks. I'm sure they would also be interested in A273 but it is not around the corner and they could be in the moderate range by the time the drug gets approved if beneficial. I have not discussed it with any of my other patients. Most would not qualify and I am sure many patients will have no interest in the drug due to the risks.

If aducanumab is approved, there will be an FDA approved risk evaluation and mitigation strategy (REMS) as there is with most medications that has potential for serious risks that require risk/benefit discussions and monitoring (including several of the MS drugs that I prescribe on a regular basis). The rems program will offer guidelines for monitoring and we will follow those guidelines. I suspect there will be a recommendation to check MRI around month 3 but possibly only if symptomatic. In the drug studies, most patients who had ARIA-E and/or ARIA-H were symptom-free and were only detected because of the MRI.

If approved, the drug will be for mild cognitive impairment and mild Alzheimer's disease. These patients are capable of making risk to benefit decisions for themselves. The medication is not going to be approved for moderate or severe Alzheimer's disease patients. I would not use it on frail patients.

The risks may unnerve the FDA. That is why I have previously stated I feel the possibility of approval is just a little better than 50:50

Constantine Lyketsos, a professor of psychiatry and behavioral sciences at Johns Hopkins Medicine, said the side effects stand out, and would make him nervous to administer aducanumab for more than a year or two for fear of having a serious ARIA event."

I would have expected better from a Johns Hopkins doctor. Most of the ARIA reactions occurred in the first 3 to 6 months of treatment. I would have no anxiety about continuing a patient who has been stable over a year.