US FDA fast-tracks Elan's Alzheimer's drug candidate

Ireland-based Elan Corp (NYSE: ELN) says that the US Food and Drug Administration has granted Fast Track Designation to its development program for ELND005 which was submitted for the treatment of neuropsychiatric symptoms (NPS) in Alzheimer’s disease (AD).

The FDA concluded that the development program for ELND005 for the treatment of NPS in AD meets their criteria for Fast Track Designation. Elan’s ongoing ELND005 clinical program includes the Phase II Study AG201 in patients with AD, who are experiencing at least moderate levels of agitation/aggression and the safety extension Study AG251.

The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll around 400 patients at multiple sites in the USA, Canada and other selected regions.