Regulators delay approval of Lilly's Alzheimer’s screen

Back to TopCommentsE-mailPrintBookmark and Share

Eli Lilly and Co. said U.S. regulators have delayed approval of Amyvid, its product to help detect Alzheimer’s disease.

The Food and Drug Administration said the company needed to create a training program to ensure brain scans are interpreted properly, Indianapolis-based Lilly said Friday in a statement.

Lilly acquired Amyvid in its $300 million purchase of Avid Radiopharmaceuticals Inc. in December. Outside advisers to the FDA voted in January against immediate approval of the imaging agent, unless Lilly established a training program. CEO John Lechleiter said earlier this month that he was confident of gaining U.S. regulatory approval and that Lilly aimed to resolve the FDA panel’s concerns in a few months.

“Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA,” Wei-Li Shao, Lilly’s brand director for Amyvid, said in the prepared statement. “We remain confident in the data submission package for Amyvid.”

On Jan. 20, an advisory panel of outside experts told the FDA that Lilly’s treatment should be approved.

Amyloid plaques are protein deposits that fill the brains of Alzheimer’s disease patients. New York-based Pfizer Inc. and Lilly are among drug companies testing medicines that remove plaque from the brain or prevent buildup in hopes of slowing the progression of the disease.

Doctors have no way to detect Alzheimer’s disease plaques until a patient dies and an autopsy is performed. Amyvid is an injected radioactive drug that adheres to plaques in the brain. This allows the plaques to be seen on a living patient using three-dimensional scan known as positron emission tomography.

Lilly spokeswoman Stefanie Prodouz said she didn’t know how long it would take to address the FDA’s concerns.

“We arranging to be having a conversation with the FDA soon to determine exactly what it is the FDA wants us to address,” she said in a telephone interview Friday. “It looks like there doesn’t need to be new trials.”

Exactly what role amyloid plays in the disease is a matter of debate. A leading theory holds that amyloid fragments cause the disease by harming brain cells. A vocal minority of researchers, including the late Mark Smith of Case Western Reserve University, have argued that amyloid is not the cause of the disease. Several agents that target amyloid have failed in patient trials.

Last August, Eli Lilly said its experimental Alzheimer’s disease drug semagacestat did not slow disease progression in two patient studies. Lilly is running two final-stage trials of another drug, solanezumab, that works against .amyloid by a different mechanism.

Lilly shares increased 34 cents, or 1 percent, to $34.47 each in mid-morning trading


Post a comment to this story

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

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
Subscribe to IBJ
  1. If I were a developer I would be looking at the Fountain Square and Fletcher Place neighborhoods instead of Broad Ripple. I would avoid the dysfunctional BRVA with all of their headaches. It's like deciding between a Blackberry or an iPhone 5s smartphone. BR is greatly in need of updates. It has become stale and outdated. Whereas Fountain Square, Fletcher Place and Mass Ave have become the "new" Broad Ripples. Every time I see people on the strip in BR on the weekend I want to ask them, "How is it you are not familiar with Fountain Square or Mass Ave? You have choices and you choose BR?" Long vacant storefronts like the old Scholar's Inn Bake House and ZA, both on prominent corners, hurt the village's image. Many business on the strip could use updated facades. Cigarette butt covered sidewalks and graffiti covered walls don't help either. The whole strip just looks like it needs to be power washed. I know there is more to the BRV than the 700-1100 blocks of Broad Ripple Ave, but that is what people see when they think of BR. It will always be a nice place live, but is quickly becoming a not-so-nice place to visit.

  2. I sure hope so and would gladly join a law suit against them. They flat out rob people and their little punk scam artist telephone losers actually enjoy it. I would love to run into one of them some day!!

  3. Biggest scam ever!! Took 307 out of my bank ac count. Never received a single call! They prey on new small business and flat out rob them! Do not sign up with these thieves. I filed a complaint with the ftc. I suggest doing the same ic they robbed you too.

  4. Woohoo! We're #200!!! Absolutely disgusting. Bring on the congestion. Indianapolis NEEDS it.

  5. So Westfield invested about $30M in developing Grand Park and attendance to date is good enough that local hotel can't meet the demand. Carmel invested $180M in the Palladium - which generates zero hotel demand for its casino acts. Which Mayor made the better decision?