Piramal Healthcare Ltd.

March 9, 2017 — Piramal Imaging SA and Isologic Innovative Radiopharmaceuticals recently announced that Health Canada ...

The U.S. Food and Drug Administration (FDA) has approved a third beta-amyloid plaque positron emission tomography (PET) imaging radiotracer to identify Alzheimer’s disease. The FDA’s approval of Piramal Imaging’s Neuraceq (florbetaben F-18 injection) comes four weeks after receiving marketing authorization in Europe. 

Piramal Imaging announced the company has submitted a detailed response to the Council on Medical Service (CMS) regarding the draft decision to limit Medicare coverage of beta-amyloid positron emission tomography (PET) imaging in dementia and neurodegenerative disease.^[1] Piramal Imaging's response, originally submitted on July 29, 2013, was posted on CMS's website as part of the public comment process, which was open through August 2. As of August 8, CMS's website indicated more than 200 people had posted responses. Piramal Imaging strongly encourages the public to continue to submit evidence to CMS showing why beta-amyloid imaging is a medically necessary diagnostic tool for appropriate Medicare populations by sending information to CAGInquiries@cms.hhs.gov.

Piramal Imaging SA, a division of Piramal Enterprises, announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted its applications for review of the investigational positron emission tomography (PET) amyloid imaging agent [18F] florbetaben. A New Drug Application (NDA) was submitted to the FDA and a Marketing Authorization Application to the EMA for [18F] florbetaben use in the visual detection of beta-amyloid in the brains of adults with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. [18F] florbetaben binds to beta-amyloid plaques in the human brain, a hallmark characteristic in Alzheimer's disease.