FDA Grants Fast Track Designation to Alzheimer's Treatment

The FDA has granted fast-track designation to Lundbeck and Otsuka’s idalopirdine, an investigational treatment for mild to moderate Alzheimer’s disease.

Idalopirdine is a selective 5HT6 receptor antagonist with a different hypothesized mechanism of action than Alzheimer’s medications currently on the market. Notably, a focus on the 5-HT6 receptor is a different approach from the amyloid and tau hypotheses that have underscored the majority of drug research on Alzheimer’s disease to date.

Idalopirdine is thought to modulate the balance between excitation and inhibition in the brain. When administered with donepezil, the drug potentiates the impact of the AChEI on ACh levels and neuronal activity.

“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 research and development at Lundbeck, in a press release. “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.”

At the moment, researchers are investigating use of idalopirdine as an adjunctive symptomatic therapy for individuals living with Alzheimer’s disease. About 2500 patients are expected to take part in the studies by the time of its conclusion.

The fast-track program facilitates frequent interactions with the FDA’s review team in order to expedite clinical development and submission of applications for products that may potentially treat serious conditions and address unmet medical needs.