A Food and Drug Administration panel is expressing doubts about the benefits of an imaging agent that may be able to alert health care providers to the potential of early stages of Alzheimer’s disease (AD). For more information on this medical development and what it may mean for the health of you and your family, keep on reading after the jump.
Eli Lilly & Co. has hot a roadblock in the approval of an imaging agent, florbetapir, which may be able to detect the presence of beta-amyloid, a common sign found in Alzheimer’s patients.
The drug, which is called Amyvid, is supposed to be used on patients receiving positron-emission tomography (PET), a type of body imaging, to show the presence of beta-amyloid. While it is not being marketing as an Alzheimer’s diagnostic tool, it may prove helpful in the early detection of the disease. The FDA, however, is unconvinced.
“Although no significant risks associated with the use of Amyvid have been identified, no convincing evidence of benefit from Amyvid PET has been demonstrated either,” FDA said in a memo late last month. “At this point in time, the regulatory and secondary clinical reviewer recommends against approving the new drug application.”
The FDA is not in the practice of approving drugs just because they aren’t harmful, and since there is known scientific link between the presence of amyloid and Alzheimer’s, they have yet to find a reason why knowing the presence of the protein prior to death is beneficial. The FDA has also found significant inconsistencies in the way many machines read the results of the scan using Amyvid. Until they can determine a clear benefit to the drug, and readers can become more accurate, they cannot yet approve its use.
Alzheimer’s is a degenerative disease, and early detection can be difficult since many patients don’t exhibit definitive signs until the condition has further progressed. Most Alzheimer’s diagnosis is done through cognitive tests, and amyloid analysis is not commonly done until after the patient has died. The presence of the protein is a common post-mortem indicator that the patient suffered from Alzheimer’s, and scientists are speculating that early detection of the protein can lead to an earlier AD diagnosis and more treatment options.
What do you think of the possibility of an early Alzheimer’s diagnosis option? Do you think the FDA should invest further testing into the approval of the imaging agent? Let us know what you think of these topics by leaving us comments, and be sure to check out the following video for more information on Alzheimer’s disease and the importance of early detection.