Eli Lilly ($LLY) failed last year to gain the FDA's approval to use its radioactive diagnostic agent Amyvid for possible Alzheimer's patients. The second time around, it has finally obtained a positive regulatory sign-off, but for a more general indication.
The company announced late Friday that the FDA approved the agent for use with PET scans to detect beta-amyloid plaque in a live patient's brain. Targeted patients can be suspected of having Alzheimer's or other causes of cognitive decline. Lilly subsidiary Avid Radiopharmaceuticals, which developed the diagnostic agent, was careful to point out that its new product will aid in Alzheimer's diagnoses, but is not a definitive tool because the plaque can also be involved in other conditions. Doctors typically don't know for sure if a patient has Alzheimer's until after the patient dies and they conduct an autopsy.
"It's estimated that 1 in 5 patients clinically diagnosed with probably Alzheimer's disease during life do not end up having Alzheimer's disease pathology upon autopsy," Avid President and CEO Daniel Skovronsky said in a statement. "The approval … offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients."
The hope is that the diagnostic will help identify the amyloid presence sooner, and subsequently determine more quickly if a patient likely has Alzheimer's. Then, doctors could begin treatments earlier in the degenerative process.
As Reuters explains, the dye binds to the beta amyloid, and physicians can then see it light up during a PET scan. The FDA rejected the initial approval application over concerns that physicians could have trouble interpreting the plaque scans. Since then, as FierceBiotech's coverage of the story tells you, the company has developed a more detailed training program. Meanwhile, General Electric and Bayer are among companies developing rival Alzheimer's diagnostics, Reuters notes.
- here's the release
- read FierceBiotech's take
- check out the Reuters story