FDA May Loosen Rules For Drug Approvals for Alzheimer’s – Post Marketing Trials Required

FDA May Loosen Rules For Drug Approvals for Alzheimer’s – Post Marketing Trials Required

March 14th, 2013 // 2:15 pm @

March 14, 2013

New Guidance for Alzheimer’s Disease To Require Post-Marketing Trials

In a constant search for the elusive fountain of youth, FDA is planning to move forward with looser rules for drug approvals for drugs that fight Alzheimer’s disease.

Last month, FDA came out with new guidelines in draft form that were posted on FDA’s website. The guidance is called “Guidance for Industry Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease”

This week, an article in the New England Journal of Medicine provided more information about FDA’s willingness to loosen the rules about how and when pharma companies measure both cognition and function. Usually, the standards in clinical testing are for efficacy and safety.

Avoid – FDA Move to Kansas 🙂

In the NEJM article, the authors wrote:

“In reviewing new-drug applications for the treatment of Alzheimer’s disease, the Food and Drug Administration (FDA) has maintained that claims of improved cognition should be accompanied by evidence of improvement in function. However, the premise that effective cognitive improvement will be manifested in the functional assessment of patients is untenable in the case of early-stage Alzheimer’s disease, which is increasingly the target of drug-development efforts.

“We simply do not yet have drug-development tools that are validated to provide measures of function in patients with Alzheimer’s disease before the onset of overt dementia. Improvement in function, moreover, could lag substantially behind cognitive improvement mediated by pharmacologic agents early in the course of the disease. In view of the devastating effects of this disease on patients and their families, along with its growing prevalence, innovative approaches to trial design and end-point selection are urgently needed, especially as the drug-development community turns its sights on early stages of the disease.”

The doctors noted in the report that researchers have been successful in finding signs of the aging disease in the brain, usually through the detection of plaque.

They also noted that to this point, drug discovery for Alzheimer’s disease has been disappointing. Several drugs have not demonstrated efficacy in large, phase III clinical trials of late stages of the disease.

One Issue

One issue in the new guidance is a requirement for more follow-up clinical trials (post marketing trials) to ensure the drugs are safe and effective. We know that sometimes pharma is not as proactive as they might be when they do these trials as there is no real incentive to do so.

Avoid – FDA Move to Kansas 🙂


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