Drugs

Report on Alopecia Patient Perspectives for Drug Development

FDA has released a report entitled The Voice of the Patient: Alopecia Areata that summarizes a 9/2017 public meeting that heard from patients and caregivers about the symptoms and health effects that matter most to alopecia patients. The report can be used by drug developers seeking to develop therapies for the condition, which currently has no FDA-approved treatments. The meeting and report are part of the agency’s initiative to rely more on patient perspectives when reviewing and approving new therapies.

The meeting provided a look into challenges and burdens facing alopecia patients, including the “debilitating emotional and psychological impact on patients which goes beyond the loss of hair,” the report says. They also conveyed the clear need for more therapeutic options for all age groups.

Additionally, the report’s Appendix 4 discusses how the patient input may directly support FDA benefit-risk assessments for medical products under review. “This input may also be of value to the drug development process more broadly,” it says. “For example, it may help drug developers understand how to develop better endpoints for clinical trials to measure those aspects of alopecia areata that are important to patients. It can help drug developers select or develop questionnaires that measure important concepts and engage with the FDA as they develop treatments. The information from these meetings can also help support the FDA review of clinical trial questionnaires to confirm that they are adequately capturing the individuals' and caregivers' perspective on health outcomes.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome