F-18 Florbetaben gets initial nod toward CE mark

Piramal Imaging, producers of the amyloid imaging PET agent F-18 florbetaben, otherwise known as NeuroCeq, announced Dec. 20 that the drug had been recommended by the Committee for Medicinal Products for Human Use (CHMP), one step away from European Commission approval.  

The decision is based on a phase III study that demonstrated NeuraCeq’s ability to detect neuritic beta-amyloid in living brains. Piramal referred to the trial’s findings of 100 percent sensitivity and 86 percent specificity for visual interpretation of amyloid PET in the first 31 brains studied. Additional analysis in a larger subject population led to 98 percent sensitivity and 89 specificity for amyloid detection. The news comes on the heels of Piramal’s acquisition of the Bayer HealthCare molecular imaging division last year.

“Alzheimer’s disease is a growing epidemic, with recent data suggesting more than six million people in Europe and 36 million people worldwide are living with Alzheimer’s,” said Swati Piramal, MD, vice chair of Piramal Enterprises. “When Piramal Enterprises acquired Bayer HealthCare's molecular imaging pipeline in 2012, we were excited about the potential for NeuraCeq as an adjunct to other diagnostic evaluations for dementia. It arms physicians with additional data to help reduce misdiagnosis of Alzheimer’s disease and may have the potential to aid in earlier diagnosis and intervention. We look forward to hearing the European Commission’s final decision.”

Piramal Imaging is partnering with IBA Molecular to manufacture and distribute the radiopharmaceutical as soon as CE approval is given. IBA Molecular is at the helm of a network of 54 PET radioisotope facilities across the globe.