FDA’s Voice of the Patient Report Released

May 23, 2018

At the end of March the Food and Drug Administration released its Voice of the Patient (VoP) Report based upon last year’s Patient Focused Drug Development (PFDD) meeting. The FDA held a public meeting on September 11, 2017, to hear perspectives from patients with alopecia areata, caregivers, and other patient representatives regarding the symptoms of alopecia areata that matter most to patients and current approaches to treating this disease.

The conclusions that the FDA drew from what they heard from patients that will drive the benefit risk assessment are powerful. Here are the conclusions worth celebrating from Appendix 4 of the VoP report:

  • Alopecia areata is a chronic disease that places a significant burden on daily life and has a severe impact on how patients feel and function.
  • Symptoms can have considerable detrimental effects on a patient’s quality of life, emotional wellbeing, social interactions, and ability to live a normal life.
  • There is a significant unmet medical need for treatments for patients with alopecia areata. No approved therapies exist, and existing off-label therapies do not adequately manage the condition for most patients.
  • Participants at the public meeting highlighted the lack of approved and effective therapies for alopecia areata, describing their condition as poorly managed by existing off-label therapies.

These conclusions are supported by the findings described in Topics 1 and 2 which are based primarily upon the patient testimony given at the PFDD meeting. 

To read the full report you can visit the FDA website: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserF...

NAAF is committed to working with the FDA and all stakeholders to ensure that people with alopecia areata have access to safe and effective treatments. We are responding to the FDA thanking them for the PFDD meeting and the VoP report and sharing our perspective on the Overview of this disease. We will continue to update the community on the patient-focused drug development process and our work with the FDA.

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