Elan Corporation Gains Fast Track Designation to Alzheimer’s Drug
- Updated: July 17, 2013
Elan Corporation, plc (NYSE: ELN) announced Wednesday that the FDA granted a Fast Track Designation to its drug, ELND005, submitted for the treatment of neuropsychiatric Symptoms associated with Alzheimer’s disease.
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 approximately 400 patients at multiple sites in the US, Canada and other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific NPS, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity.
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Disclosure: At the time of this writing, the author had no position in the company mentioned.
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