Anavex Life Sciences Corp (AVXL)

[sokol]

UsAgainstAlzheimer’s organization is urging people to contact the FDA to advocate for approval of Biogen’s aducanumab, which they say would be the first disease modifying drug for Alzheimer’s.

An FDA advisory panel previously declined to recommend approval. Biogen’s drug failed at first. Later, Biogen and its partner, Eisai, obtained a different outcome with a new measure of efficacy. They came up with a new standard to measure ”success” to seek FDA approval despite the prior failure of the drug and despite side effects. Among the side ef­fects that the com­pa­nies reported were re­ac­tions at the sites of the in­fu­sion and swelling around blood ves­sels ob­served with brain imag­ing.

The drug is IV injected, meaning multiple trips are made to a clinic for injections.