Bayer (BAYGn.DE) has started enrolling participants for the last stage of testing of its Alzheimer’s marker florbetaben, which could offer a way to diagnose early onset of the disease, the drugmaker said on Monday.
About 400 individuals will be enrolled for the third phase of testing usually required for regulatory approval, to assess its potential to detect the debilitating disease.
In a Phase II study, florbetaben was shown to help diagnose the illness in eight out of 10 cases, it had said in June.
Injection of florbetaben highlights beta-amyloid plaques, which are associated with Alzheimer’s, in patients’ brains under a positron emission tomography (PET) scan.
Currently, the illness can only be reliably diagnosed when symptoms such as memory loss, language breakdown and impaired movement are advanced and only a post-mortem brain tissue examination can bring absolute certainty.
The company does not provide an annual peak sales estimate for the product.
Via Bayer Starts Phase II Study for Alzheimer Test
This fall, researchers from Saint Louis University will begin testing an intriguing new approach to slowing down the progression of Alzheimer’s Disease using Intravenous Immune Globulin (IGIV), also known as gammaglobulin. IGIV is currently used to treat primary immunodeficiency disorders but is not currently approved for treating AD, which is one of the leading causes of dementia in the elderly.
Investigators will examine whether IGIV, which is made from the blood of several thousand healthy adults and contains naturally occurring human anti-amyloid antibodies, will defend the brain of AD patients against the damaging effects of beta amyloid, the protein that forms the core of plaques in the brain, with the hope that giving IGIV to patients with mild to moderate Alzheimer’s may potentially slow the rate of progression of the disease.
Via SLU Researchers to Test Gammaglobulin for Alzheimer’s Disease
The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co. said Friday.
Bristol-Myers and Otsuka Pharmaceutical Co., based in Tokyo, are collaborators on the development and distribution of Abilify in the U.S. and Europe.
Abilify is Bristol-Myers’ second-biggest revenue generator, with $2.2 billion in 2008 sales.
The FDA’s latest approval allows the drug to be used to treat symptoms associated with autism such as aggression toward others, deliberate infliction of self-injury, tempter tantrums and moodiness.
The companies said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological and social aspects.
via FDA Approves Abilify for Autism-linked Irritability