Transition Therapeutics' ELND005 program for treatment of Neuropsychiatric Symptoms (NPS) in Alzheimer's disease (AD) gets US FDA Fast Track Designation grant
Singapore: US FDA has granted Fast Track Designation to the development program for Transition Therapeutics' 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.
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.
It is currently estimated that approximately 5.4 million Americans and approximately 7.2 million Europeans have AD and these numbers are expected to rise to 16 million by 2050. AD is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgements, communicate and carry out daily activities.
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