Alzheimer’s Placebo May Become Disease-Modifying Drug For Affiris
This article was originally published in The Pink Sheet Daily
Biotech shifts development plans after Phase II study shows surprising, but promising, results – albeit in the wrong arm of the study.
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With the termination of a Phase II trial of LY2887621, Merck’s MK-8931 leads the race to become the first BACE inhibitor approved for Alzheimer’s, although four other companies have similar candidates in earlier stages of development. Lilly says it may continue to pursue BACE inhibition in Alzheimer’s.
Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of Alzheimer’s in the hopes of finding an effective drug before too much damage is done. FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.
A draft guidance for development of drugs to treat early Alzheimer’s disease does not loosen agency standards, FDA’s neurology products chief asserts. Rather, it is an attempt to establish criteria tailored to the population.