Piramal Imaging SA, a division of Piramal Enterprises, has announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted its applications for review of the investigational PET amyloid imaging agent florbetaben.
A New Drug Application (NDA) was submitted to the US FDA and a Marketing Authorization Application (MAA) to the EMA for florbetaben use in the visual detection in the brains of adults who are being evaluated for Alzheimer's disease and other causes of cognitive decline.
In April last year, Piramal Healthcare Ltd had acquired worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG. With the buyout, company had received rights to florbetaben that help to detect signs of Alzheimer’s disease.
Piramal estimates that the new class of PET imaging agents for Alzheimer's has a global market potential of up to $1.5 billion.