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Posted by on May 25, 2012 in FDA, Neurology, Neuropsychiatry, Pharma

Elan Predicting FDA Approval of Bapineuzumab for AD? Telegraphing “Modicum of Benefit”

Elan Predicting FDA Approval of Bapineuzumab for AD? Telegraphing “Modicum of Benefit”

There’s tremendous speculation on the pending outcome of phase 3 results with bapineuzumab, 1 of 2 anti-amyloid compounds in late-stage development for Alzheimer disease. The general buzz is that the monoclonal antibody won’t perform tremendously well, given phase 2 resultsspecifically those indicating tepid efficacy and limited safety (particularly regarding vasogenic brain edema). But Elan chief executive Kelly Martin, whose company has a 25% stake in the drug (along with Pfizer and Janssen [ie, JNJ]), is doing what drug execs do: talking up the company’s prospects vis-a-vis its pipeline. In this case, the prospects hinge mightily on bapineuzumab, the phase 3 results for which won’t be publicly available until the “middle of the year,” Martin confirms.

But there is other telegraphed information in Elan’s latest public cheerleading for bapineuzumab. That is: the phase 3 results for the MAb won’t be a clear home run, but that the compound may show some clinical benefit, however marginal. Elan’s chairman, Robert Ingram, appears to predict FDA approval for bapineuzumab on the basis of 2 complementary forces: 1) increasing pressure on the agency to approve something for AD; and 2) the probability that company statisticians will be able to demonstrate some clinical benefit of the drug at least in some subset of AD patients (like those who aren’t APOE e4 carriers).

The telling quote from the Elan chairman: “The FDA won’t approve the drug if it doesn’t
have a single benefit but they are signalling that they will be very
reasonable about getting something to patients that has a modicum of
[emphasis added]”

And this statement predicts a really unsatisfactory outcome for bapineuzumab’s clinical development and, more importantly, the therapeutic prospects for patients with AD and their caregivers. That is: there won’t be a clear-cut thumbs up or thumbs down for the MAb, because the efficacy and safety data won’t allow a clear-cut thumbs up, and the backing companies and prevailing zeitgeist won’t allow a clear-cut thumbs down. In other words, the drug, at best, may provide some benefit (however minimal or marginal) in AD (or more likely, a subset of AD patients) that may or may not outweigh safety concerns. And Elan, more or less, predicts that the FDA will be pressured to approved the iffy* drug, because there’s no other disease-modifying** option on the market.

That’s a disappointment all-around.

* And likely, very expensive.
** That is, putative disease-modifying option.

bmartin (80 Posts)

A native East Tennessean, Barbara Martin is a formerly practicing, board-certified neurologist who received her BS (psychology, summa cum laude) and MD from Duke University before completing her postgraduate training (internship, residency, fellowship) at the Hospital of the University of Pennsylvania in Philadelphia. She has worked in academia, private practice, medical publishing, drug market research, and continuing medical education (CME). For the last 3 years, she has worked in a freelance capacity as a medical writer, analyst, and consultant. Follow Dr. Barbara Martin on and Twitter.