Elan Gets FDA Fast Track for Alzheimer’s Drug

Drug giant Elan (NYSE:ELN) scored fast track designation from U.S. regulators on Wednesday for its treatment designed to reduce symptoms in patients with moderate to severe Alzheimer’s disease.

The drug, known formally as ELND005, is being developed as a treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s. Elan’s ongoing mid-stage study involves 400 patients during a 12-week period with “at least moderate levels” of agitation or aggression.

The Food and Drug Administration said Wednesday ELND005 met its fast-track requirements for drugs intended to treat serious or life-threatening conditions, thus allowing it to help facilitate the development and expedite the review. The designation allows for more frequent conversation with the FDA and opens the door up for potential priority review.

In a previous Phase 2 study for the drug, Elan said ELND005 appeared to decrease the emergence and severity of specific NPS and led to a sustained reduction of brain Myo-inositol levels, which tend to rise in certain brain disorders including Alzheimer’s.

“ELND005 is an orally bioavailable small molecule that is being investigated by Elan for multiple neuropsychiatric indications on the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregation and regulation of brain myo-inositol levels,” Elan said.

While roughly 5.4 million Americans and 7.2 million Europeans currently suffer from Alzheimer’s disease, those numbers are expected to rise to 16 million by 2050, according to estimates cited by Elan.

The Irish drug giant said some 90% of Alzheimer’s patients develop NPS, and up to 60% develop agitation/aggression over the course of their disease.

Shares of Elan traded narrowly higher around $14.15 in recent trade. They are up 39% year-to-date.