Date: 2014-08-22
Type of information: Granting of a Market Authorisation in the EU
Product name: Vizamyl®
Compound: flutemetamol F 18 injection
Therapeutic area: Neurodegenerative diseases
Action mechanism: Vizamyl® works by attaching to beta amyloid and producing a PET image of the brain that is used to evaluate the presence of beta amyloid. A negative Vizamyl scan means that there is little or no beta amyloid accumulation in the brain and the cause of the dementia is probably not due to AD. A positive scan means that there is probably a moderate or greater amount of amyloid in the brain, but it does not establish a diagnosis of AD or other dementia. Vizamyl does not replace other diagnostic tests used in the evaluation of AD and dementia
Company: GE Healthcare (USA)
Disease: diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer\'s disease (AD) and dementia
Latest news: * On September 1, 2014, GE Healthcare announced that Vizamyl® (flutemetamol (18F) solution for injection) has received marketing authorisation from the European Commission as a radiopharmaceutical medicinal product indicated for Positron Emission Tomography (PET) imaging of beta amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. Vizamyl® will be commercially available in selected European countries from early 2015. Vizamyl® is for diagnostic use only and should be used in conjunction with a clinical evaluation.The marketing authorisation for Vizamyl® was based on review of data from a series of Phase III clinical trials, including brain autopsy studies which showed high sensitivity and specificity for visual interpretation of flutemetamol (18F) PET images, using beta amyloid pathology as the standard of truth. Additionally, to instruct physicians in accurate interpretation of Vizamyl® images, GE Healthcare has developed an electronic reader training program (ETP), which, following approval, will be offered free of charge as online and in-person training in the European Union. Images should be interpreted only by readers who have completed the GE Healthcare electronic reader training program. * On 26 June 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Vizamyl®, 400 MBq/mL, solution for injection intended for the diagnosis of patients investigated for Alzheimer’s disease. The benefits with Vizamyl® are its ability to help detect with a high accuracy the beta-amyloid deposition, and therefore contribute valuable additional information in the diagnostic process in Alzheimer’s disease. The most common side effects are flushing, increased blood pressure, headache, dizziness and nausea. A pharmacovigilance plan for Vizamyl® will be implemented as part of the marketing authorisation.
* On October 25, 2013, the FDA has approved Vizamyl® (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer\'s disease (AD) and dementia.Vizamyl’s effectiveness was established in two clinical studies comprised of 384 participants with a range of cognitive function. All participants were injected with Vizamyl® and were scanned. The images were interpreted by five independent readers masked to all clinical information. A portion of scan results were also confirmed by autopsy. The study results demonstrate that Vizamyl® correctly detects beta amyloid in the brain. The results also confirm that the scans are reproducible and trained readers can accurately interpret the scans. Vizamyl®’s safety was established in a total of 761 participants.
Vizamyl® is not indicated to predict the development of AD or to check how patients respond to treatment for AD. Vizamyl PET images should be interpreted only by health care professionals who successfully complete training in an image interpretation program. The Vizamyl® drug labeling includes information about image interpretation.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2013-10-25
UE authorization: 2014-08-22
Favourable opinion UE: 2014-06-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
