Vizamyl amyloid PET agent moves one step closer to CE mark
The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has given an encouraging nod toward final approval for European marketing of the amyloid-aiming PET agent F-18 flutemetamol (Vizamyl).
The diagnostic radiopharmaceutical, developed by GE Healthcare, is designed for visualization of amyloid neuritic plaque density in cognitively impaired subjects being assessed for dementia, including Alzheimer’s disease, and other neurologic causes of cognitive decline.
“The CHMP positive recommendation further strengthens GE Healthcare’s longstanding commitment to the early and accurate detection of AD pathology and to improving quality of life for patients and their caregivers,” said Kieran Murphy, GE Healthcare Life Sciences President and CEO, in a press release. “When approved in the European Union, Vizamyl will be an important tool to support assessments of patients with cognitive disorders, including AD.”
The CHMP recommendation was hinged on the demonstration of efficacy data in a number of clinical trials. These include phase III biopsy and brain autopsy studies for the confirmation of amyloid pathology picked up by Vizamyl PET imaging.
Vizamyl, like other amyloid PET agents, is not approved for the diagnosis of Alzheimer’s, but to provide diagnostic clarity alongside clinical evaluation.
“[Alzheimer’s disease] is a major unmet medical need and the lack of diagnostic tools increases the potential for diagnostic uncertainty and the risk of mismanagement,” said Philip Scheltens, PhD, professor of cognitive neurology and director of the Alzheimer Center at the VU University Medical Center, Amsterdam. “Once approved, Vizamyl may help physicians to assess specific patients with suspected Alzheimer’s disease. This may help physicians determine appropriate treatment options, support patients and caregivers in planning for the future, and support clinical researchers in identifying patients for clinical trials.”
Vizamyl was approved for commercialization in the U.S. in October of last year.