US FDA grants Alzheimer’s drug fast track status
The US Food and Drug Administration has granted Fast Track Designation to Transition Therapeutics’ development program for ELNDOO5, which was submitted for the treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer’s disease (AD).
ELND005 is currently being evaluated in a 12-week clinical trial of patients with moderate to severe AD, who are experiencing at least moderate levels of agitation and aggression. Approximately 400 patients at multiple sites in the US, Canada and other selected regions are expected to enroll.
The US FDA concluded that the Canadian biopharma company’s current development program meets its criteria for Fast Track Designation, which means that Transition’s new drug application (NDA) may be considered for priority review when it comes to approval.
The FDA’s Fast Track is designed to facilitate the development and speed up the review of new drugs that are intended to treat serious or life-threatening conditions.
Transition’s licensing partner, Elan Corporation, is responsible for all development and commercialization activities and costs of ELND005.
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