The FDA's new "breakthrough" product designation allows new drugs to win approval after just a single round of testing, instead of the usual three. A total of three promising experimental medicines have been assigned the new status so far, while an additional 18 drugs have applied. The new designation follows three other programs -- Fast Track, Priority Review and Accelerated Approval -- each of which were designed to help bring crucial new drugs to market in a shorter amount of time.
"A breakthrough drug is one that may offer important new benefits for patients with serious or life-threatening disease who are especially in need of new safe and effective treatments," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
This is very interesting. I'm not sure if would be targeted at drugs for Alzheimers though -- the initiative seems to be targeted at drugs that address diseases with relatively short life expectancy after diagnosis (e.g. pancreatic or stomach cancer) without a drug. Alzheimers patients often live a decade or more after diagnosis. People with Huntington's disease also have a long expected life span after diagnosis. I've noticed over on the Sarepta board, some stock owners seem to believe that this new pathway may help Sarepta get its Duchenne muscular dystrophy drug approved faster.
Another company I believe is pursuing it is Neuralstem (CUR) which has so far documented some anecdotal success with their stem cell trial for ALS, with full results yet to be revealed. ALS is terminal, often within 2 years and there is no treatment.