Eli Lilly's dye to help diagnose Alzheimer's approved
The test can help clinicians and patients get more answers about their conditions.
The dye, which is used in an imaging test, is the first and only of its kind. While it cannot definitively diagnose Alzheimer's, it can help doctors detect it sooner and more accurately. It can also help rule out the disease.
The dye, called Amyvid, is a radioactive diagnostic agent injected into the bloodstream. The dye binds to amyloid plaques, which are clumps of a protein often found in the brains of Alzheimer's disease patients. It is then detected in a PET scan of the patient's brain.
Not a definite diagnosis
If the test shows little-to-no plaque in the brain, it reduces the likelihood the patient has Alzheimer's. However, the plaque may also be present in patients with other types of neurological conditions and in older people with normal cognition.
Currently, the only definitive way to diagnose Alzheimer's is after death through a brain autopsy. According to Dr. Daniel Skovronsky, CEO of Avid, the Lilly unit that will market the dye, it's estimated that one in five diagnosed patients do not actually end up having Alzheimer's once an autopsy is conducted. "The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients," Skovronsky said in a statement.
Last year, an FDA panel recommended against approving the dye because it was concerned about misinterpretations of the test. Lilly has since worked on ways to improve training for doctors. The imaging test is only to be used alongside other tests.
According to Reuters, the market for imaging agents for Alzheimer's is estimated to have a potential global value of between $1 billion and $5 billion. While Lilly's Avid has been leading the race, General Electric (GE) and Bayer AG are also developing products.
Amyvid will be available in limited quantities starting in June, Lilly said. It will cost $1,600 a dose, according to the Wall Street Journal.
Alzheimer's -- a growing and challenging disease
Alzheimer's disease is a form of dementia -- loss of brain function -- that gradually gets worse over time. It affects memory, thinking, and behavior. There is no cure for Alzheimer's; the goals of treatment are to slow the progression of the disease and manage its symptoms.
Currently, 5.4 million Americans are living with Alzheimer's, according to the Alzheimer's Association, and 35 million worldwide. It is the sixth-leading cause of death in the U.S. In 2012, the direct costs associated with Alzheimer's or other dementias will total an estimated $200 billion, including $140 billion in costs to Medicare and Medicaid. This cost is projected to soar to $1.1 trillion by 2050.
The Alzheimer's research arena has been particularly challenging and littered with failures, some of them by Lilly itself. Many researchers believe that early diagnosis can help improve treatment outcomes. That's where the new test from Lilly can possibly help. Not only that, it can help track the progression of the disease, the Wall Street Journal explains.
Lilly's fourth-quarter profit slid 27% after it lost patent protection on its schizophrenia drug Zyprexa last year. In the past few years, it has shied away from large mergers and concentrated on its R&D, as many of its drugs are going off-patent, but so far with limited results.
While the approval of the imaging test may not have an immediate impact on Lilly's stock, it may help in the development of several of its potential Alzheimer's treatments, including solanezumab. Results of this experimental drug's phase III study are expected this summer. Pfizer (PFE) and Johnson & Johnson (JNJ) are also developing several similar medicines, notably bapineuzumab.
What's most important, though, is that the test is progress of sorts in this very difficult field.
Melly Alazraki is a freelance financial writer who frequently covers the pharmaceutical industry. She holds no positions in the stocks mentioned.
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