FDA gives idalopirdine Fast Track Designation
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Development & Commercialization Inc. have developed the agent to treat mild to moderate Alzheimer’s disease.
Idalopirdine, a selective 5-HT6 receptor antagonist, has a different hypothesized mechanism for acting compared to the medications that are currently available for Alzheimer’s. The traditional amyloid and tau hypotheses treatments have been the foundation of most of the drug research revolving around Alzheimer’s.
There are currently four separate clinical phase-three studies evaluating idalopirdine’s potential for an adjunctive symptomatic therapy, starting in October 2013. Experts believe the studies will enroll an estimated 2,500 patients around the world.
“We are pleased about the opportunity for priority review for idalopirdine and potentially provide a new option for patients in the battle against Alzheimer’s disease, for which there still are substantial unmet needs,” Anders Pedersen, executive vice president at Lundbeck, said. “Lundbeck and Otsuka are committed to developing an innovative portfolio of drugs to tackle symptoms of Alzheimer’s disease and the FDA Fast Track designation may secure a smoother and faster regulatory process to help us meet that goal.”
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