Pfizer, J&J’s Alzheimer’s Drugs To Get Boost from FDA Trial Rules

Pfizer, J&J’s Alzheimer’s Drugs To Get Boost from FDA Trial Rules

July 12th, 2011 // 12:53 pm @

There are no good drugs yet for treating Alzheimer’s disease, which is notoriously complex and poses many challenges to developers. Yet with the nudging of industry and academics, the FDA has loosened some safety restrictions on trials for amyloid-lowering drugs against the disease, making it that much easier for companies like Pfizer, J&J and Eli Lilly to advance their experimental treatments, Reuters reports today.

Since a dozen Alzheimer’s patients had brain-swelling condition in a 2008 study of Pfizer ($PFE) and J&J’s ($JNJ) drug bapineuzumab, the FDA has made developers perform additional testing on patients who are in trials for such treatments and has restricted patients from participating if they have had more than two occurrences of certain small blood leaks in the brain, Reuters reports. With so many Alzheimer’s patients experiencing such leaks, however, it’s made it tough to get patients into trials and potentially slowing progress against the disease. So the FDA is letting some of the patients who have experienced the blood leaks to participate in the trials.

“We don’t want to compromise safety, but we also want to make sure as many people as possible can participate in Alzheimer’s clinical trials,” said Maria Carrillo of the Alzheimer’s Association, which advocated for easing the trial restrictions, told Reuters. Her group worked with industry and academics on a report on the topic that was published yesterday in the journal Alzheimer’s and Dementia.

There’s a lot at stake in the development of Alzheimer’s drugs for developers and patients. There are an estimated 5 million Americans and 26 million patients worldwide with the disease, and no drugs that address the root causes of the illness have been approved. While there’s certainly skepticism about whether amyloid-lowering drugs are the answer, those experimental medicines a least offer a shot at progress.


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