Lundbeck, Otsuka’s trial Alzheimer’s disease drug gets US FDA fast track designation
pharmafile | July 8, 2016 | News story | Medical Communications, Research and Development | Alzheimer's disease, Lundbeck, Otsuka, US FDA, drug development, drug trial, fast track designation
H. Lundbeck A/S (CPH: LUN) and Otsuka Pharmaceutical said the US Food and Drug Administration (FDA) have granted Fast Track Designation to the trial agent idalopirdine to treat Alzheimer’s disease.
Anders Gersel Pedersen, executive vice president and head of R&D 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.”
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, the companies said in a joint sattement.
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 enrol about 2,500 patients worldwide.
Alzheimer’s disease is a progressive brain disorder in which the brain gradually degenerates. It most frequently occurs in people above 65 years of age. People with Alzheimer’s disease develop distressing changes in memory, thought, function and behavior, which worsen over time. Worldwide, 47.5 million people have dementia. Every year, there are 7.7 million new cases.
The total number of people with dementia is projected to 75.6 million in 2030 and almost triple by 2050 to 135.5 million. Alzheimer’s disease is the most common cause of dementia, accounting for 60 to 80% of these patients.
Anjali Shukla
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