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Lilly wins FDA approval for Alzheimer's imaging agent

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Eli Lilly and Co. says it has won approval from the U.S. Food and Drug Administration for a new imaging agent that could help physicians better diagnose Alzheimer’s disease and other forms of dementia.

The agent, called Amyvid, is not expected to produce high-dollar sales for Lilly, but it could help to identify patients with Alzheimer’s—and those without it—earlier than other methods, perhaps improving treatment and focusing research efforts.

Indianapolis-based Lilly is currently studying an experimental treatment for Alzheimer’s disease, solanezumab, which if successful, could become a multibillion-per-year blockbuster and reverse Lilly’s recent struggles with expiring patents on its older blockbuster products. No treatment exists that slows or reverses the progression of Alzheimer's disease, which currently afflicts about 30 million people worldwide and is expected to afflict three times that number by 2050.

However, even Lilly officials say the chance of the solanezumab's success is low. That’s because scientists do not completely understand what causes Alzheimer’s disease. So efforts by Lilly and other major pharmaceutical companies to develop treatments is based so far on unproven theories.

Lilly’s scientists have followed the theory that Alzheimer’s is caused by the buildup of the protein beta-amyloid in a patient’s brain, which eventually forms sticky plaques that impede brain function. Solanezumab binds to amyloid in an effort to remove it from the brain via the bloodstream. And the imaging agent Amyvid binds to amyloid plaques, making them detectable using a PET scan.

Previously, the presence of amyloid plaques could only be confirmed by an autopsy, after a patient’s death. And sometimes the diagnosis of Alzheimer’s was proved wrong.

"It's estimated that one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not end up having Alzheimer's Disease pathology upon autopsy," said Dr. Daniel Skovronsky, CEO of Avid Radiopharmaceuticals Inc., the company that developed Amyvid, and which Lilly acquired in 2010 for $300 million. "The approval of Amyvid offers physicians a tool that, in conjunction with other diagnostic evaluations, can provide information to help physicians evaluate their patients."

Amyvid will become available in limited supplies in June. The FDA approval comes more than a year after the agency was first scheduled to make a decision on the drug.

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  1. In reality, Lilly is maintaining profit by cutting costs such as Indiana/US citizen IT workers by a significant amount with their Tata Indian consulting connection, increasing Indian H1B's at Lillys Indiana locations significantly and offshoring to India high paying Indiana jobs to cut costs and increase profit at the expense of U.S. workers.

  2. I think perhaps there is legal precedence here in that the laws were intended for family farms, not pig processing plants on a huge scale. There has to be a way to squash this judges judgment and overrule her dumb judgement. Perhaps she should be required to live in one of those neighbors houses for a month next to the farm to see how she likes it. She is there to protect the people, not the corporations.

  3. http://www.omafra.gov.on.ca/english/engineer/facts/03-111.htm Corporate farms are not farms, they are indeed factories on a huge scale. The amount of waste and unhealthy smells are environmentally unsafe. If they want to do this, they should be forced to buy a boundary around their farm at a premium price to the homeowners and landowners that have to eat, sleep, and live in a cesspool of pig smells. Imagine living in a house that smells like a restroom all the time. Does the state really believe they should take the side of these corporate farms and not protect Indiana citizens. Perhaps justifiable they should force all the management of the farms to live on the farm itself and not live probably far away from there. Would be interesting to investigate the housing locations of those working at and managing the corporate farms.

  4. downtown in the same area as O'malia's. 350 E New York. Not sure that another one could survive. I agree a Target is needed d'town. Downtown Philly even had a 3 story Kmart for its downtown residents.

  5. Indy-area residents... most of you have no idea how AMAZING Aurelio's is. South of Chicago was a cool pizza place... but it pales in comparison to the heavenly thin crust Aurelio's pizza. Their deep dish is pretty good too. My waistline is expanding just thinking about this!

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