The US Food and Drug Administration (FDA) plans to lower the evidentiary bar needed for an Alzheimer's treatment to gain approval. According to draft guidelines released in February and described by agency officials on 13 March in the New England Journal of Medicine (http://doi.org/kv7, 2013), drugs targeted at patients early in the course of their disease could be initially approved off the back of improvements in cognition (such as memory) alone, with functional gains on daily chores demonstrated later through post-marketing studies.
Parkinson's and Alzheimer's disease presentations at the 65th American Academy of Neurology (AAN) Annual Meeting in San Diego from 16 to 23 March tended toward imaging and biomarker studies rather than clinical trial data for therapeutics, but some drug trial results were presented at the week-long conference.
The amount of new data for Parkinson's and Alzheimer's drugs paled in comparison to results for multiple sclerosis therapies, but that may reflect plans to present data at specialized conferences later in 2013 rather than a lack of development in those diseases. Still, efforts are under way to encourage investment in new therapies given the progressive nature and growing number of patients with Parkinson's and Alzheimer's diseases.
About 5.2 million people in the United States are estimated to have Alzheimer’s disease in 2013, according to the Alzheimer’s Association.
Patients with the condition have a progressive loss of cognitive functioning, which includes memory and language.
Multiple sclerosis affects more than 2.1 million people throughout the world, with women having the disorder two to three times more often than men, noted the National Multiple Sclerosis Society.
Howard Fillit, executive director and chief scientific officer at the Alzheimer's Drug Discovery Foundation (ADDF) in New York, is optimistic about the Alzheimer's field despite multiple high-profile setbacks for late-stage therapeutics seeking to slow or stop progression of the disease.
"It's been a very intensive time for us in the field. There has been a lot of good news and research advances even though we haven't found a cure yet," Dr Fillit said in a recent interview with Scrip about current and future Alzheimer's drug development.
Here's how Melvin R. Goodes, the retired chief executive of Warner-Lambert, answers the question, "Mel, how are you?"
"Not bad for a guy with Alzheimer's," he responds. That Mr. Goodes approaches this question honestly and with a sense of humor is just the point.
"I'm very open about all this," says Mr. Goodes, 77 years old. "A lot of people who have gone through this kind of thing may become terribly reticent to go out in public. I just adopted a different attitude."
The tiny company whose technology underpins the development of the experimental anti-beta-amyloid antibodies being developed as an Alzheimer's prophylactic by Janssen, Elan, and Pfizer is looking to leapfrog that approach and develop a second line of attack for Alzheimer's disease therapeutics.
While the patent for its Antisenilin technology underlying two amyloid therapeutics under development by Pfizer have been challenged at the European Patent Office (EPO), New York-based Intellect Neurosciences has engaged researchers at the University of California, Irvine (UCI) to study RV03, the company’s preclinical immunotherapy created with its Recall-Vax technology to target the delta tau protein as well as beta-amyloid, which could be the first prophylactic Alzheimer’s vaccine.