IBJNews

Lilly wins FDA approval for Alzheimer's imaging agent

Back to TopCommentsE-mailPrintBookmark and Share

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.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. You are correct that Obamacare requires health insurance policies to include richer benefits and protects patients who get sick. That's what I was getting at when I wrote above, "That’s because Obamacare required insurers to take all customers, regardless of their health status, and also established a floor on how skimpy the benefits paid for by health plans could be." I think it's vital to know exactly how much the essential health benefits are costing over previous policies. Unless we know the cost of the law, we can't do a cost-benefit analysis. Taxes were raised in order to offset a 31% rise in health insurance premiums, an increase that paid for richer benefits. Are those richer benefits worth that much or not? That's the question we need to answer. This study at least gets us started on doing so.

  2. *5 employees per floor. Either way its ridiculous.

  3. Jim, thanks for always ready my stuff and providing thoughtful comments. I am sure that someone more familiar with research design and methods could take issue with Kowalski's study. I thought it was of considerable value, however, because so far we have been crediting Obamacare for all the gains in coverage and all price increases, neither of which is entirely fair. This is at least a rigorous attempt to sort things out. Maybe a quixotic attempt, but it's one of the first ones I've seen try to do it in a sophisticated way.

  4. In addition to rewriting history, the paper (or at least your summary of it) ignores that Obamacare policies now must provide "essential health benefits". Maybe Mr Wall has always been insured in a group plan but even group plans had holes you could drive a truck through, like the Colts defensive line last night. Individual plans were even worse. So, when you come up with a study that factors that in, let me know, otherwise the numbers are garbage.

  5. You guys are absolutely right: Cummins should build a massive 80-story high rise, and give each employee 5 floors. Or, I suppose they could always rent out the top floors if they wanted, since downtown office space is bursting at the seams (http://www.ibj.com/article?articleId=49481).

ADVERTISEMENT