Alopecia: FDA Discusses Meeting on Patient-Focused Drug Development

Regulatory NewsRegulatory News | 28 March 2018 |  By 

Following a public meeting last September to hear perspectives from patients, parents and others with alopecia areata, an autoimmune disease that causes hair loss, the US Food and Drug Administration (FDA) on Wednesday published a report summarizing the input shared and what matters most to patients.

The meeting was part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), during which the agency held 24 public meetings. The alopecia areata public meeting was the agency’s 23rd of such meetings.


“Overall, participants reported feelings of frustration at the lack of treatment options available for alopecia,” the report on the meeting and comments submitted to the public docket says. “Participants described most of the existing treatment options, especially corticosteroids, as being either ineffective or only temporarily effective, and paired with too many downsides. Participants emphasized the need for additional treatment options for their condition.”

In terms of the daily impact, patients most commonly mentioned the emotional toll of alopecia, FDA notes, in addition to the stigma and social isolation, often in the form of bullying and being misunderstood by classmates and coworkers, and difficulties in finding and maintaining personal and romantic relationships, as well as participating in physical activities.

As far as treatments, the most commonly used type of prescription medication participants reported using was corticosteroids, though many participants said they “often were ineffective and caused significant downsides.”
Several participants reported trying various kinds of immunosuppressants, such as methotrexate and tacrolimus, though according to FDA, “Few participants stated that these treatments were highly effective.”

Several also “noted that they had achieved some success in hair regrowth with the drug Xeljanz. Some participants described their experiences in a positive light, saying that they had regrown scalp hair, eyebrows, and eyelashes to varying degrees … Other participants addressed the potential downsides of Xeljanz, including two participants whose doctors did not prescribe the drug due to risk of infection.”

As for an ideal treatment, FDA notes a range of perspectives, though for many, “simply stopping the additional loss of hair and maintaining what they currently have would not count as meaningful benefit to them.”

FDA also summarized the comments submitted to the public docket, which it said “emphasized the psychological, physical, and economic impact of alopecia.”

The Voice of the Patient: A series of reports from the U.S. Food and Drug Administration’s (FDA’s) Patient-Focused Drug Development Initiative. Alopecia Areata.


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