Lundbeck and Otsuka Pharmaceutical Development & Commercialization has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational agent idalopirdine for the treatment of mild to moderate Alzheimer’s disease.
Idalopirdine is a selective 5HT6 receptor antagonist with a different hypothesized mechanism of action than currently available Alzheimer’s medications. Notably, a focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underpinned much of the drug research to date on Alzheimer’s disease.
“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,” said Anders Gersel Pedersen, Executive Vice President and Head of R&D at Lundbeck. “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.”
Four clinical phase III studies are underway investigating idalopirdine as an adjunctive symptomatic therapy for patients with mild to moderate Alzheimer’s disease. Clinical phase III development was initiated in October 2013 and the program is expected to enroll approximately 2,500 patients worldwide.