UPDATED: FDA proposes to dramatically lower the bar on...

UPDATED: FDA proposes to dramatically lower the bar on Alzheimer's drugs
March 14, 2013 | By John Carroll

Just weeks after pointing R&D groups engaged in Alzheimer's drug research to early-stage patients, the FDA is proposing to lower the bar biotechs will have to clear in order to gain an approval. And faced with a string of blockbuster collapses in Phase III, regulators are signaling a greater willingness to offer early, accelerated approvals for the most promising therapies that come out of the pipeline.
Up to now, the FDA has required drug developers to demonstrate improvements in both cognition and function in order for a drug developer to gain an approval. Simply put, patients in the study would not only have to demonstrate improved memory and acuity compared to a placebo group, they would also have to do better at simple daily chores like dressing themselves.
That's proven a devilishly hard target, eluding Big Pharma groups which have poured billions of dollars into new drugs only to come up short on late-stage development. But there's been a growing belief that patients diagnosed with the disease are often too damaged to benefit from therapies. As a result, the FDA has been urging drug developers to move their target to early-stage or high-risk patients, and the agency is now looking to adopt new guidances to assist the biopharma companies on trial designs that can use a new standard focused on cognitive improvements alone or preventive measures proven with biomarkers.
These new standards--initially addressed in a new draft guidance last month--could radically alter the R&D landscape for Alzheimer's drugs, widely perceived as a golden ticket to instant blockbuster status. They could also open a pathway to new therapies that could help millions of patients grapple with a mysterious and terrible disease.