GE Healthcare, a division of General Electric, announced that it had moved closer to regulatory approval for flutemetamol. Flutemetamol is an imaging agent designed for use with positron emission tomography (PET) scans. In particular, the imaging agent shows promise in diagnosing Alzheimer’s disease at an early stage.
Due to regulatory differences, FDA clearance in the U.S. and CE Mark clearance in the E.U. are usually separated by several months or years. In prepared remarks, GE Healthcare manager Jonathan Allis said, “It’s huge.” He continued, “Flutemetamol is one part to the approach of [Alzheimer’s treatment.] But it’s a big part.”
According to information from the company, the entry of flutemetamol into the E.U. and U.S. markets would be a huge advance is the diagnosis of Alzheimer’s disease. Current products on the market are unable to confirm beta amyloid buildup. Instead, the presence of beta amyloid plaque is confirmed in post-mortem autopsies. This gives physicians a larger window of opportunity for treating this disease.
A Phase III clinical study confirmed the efficacy of flutemetamol at diagnosing Alzheimer’s disease. In the study, physicians were able to detect beta amyloid plaques with 75 to 100 percent median sensitivity in 180 end-of-life patients. The clinical trial also showed 99 to 100 percent specificity.
Merck, a healthcare company working on the development of MK-8931, an Alzheimer’s drug, has licensed flutemetamol from GE Healthcare. Flutemetamol is also licensed to Johnson & Johnson and an additional undisclosed company.