Industry Perspective on Alopecia Areata.

Recent advances in our understanding of the autoimmune basis of alopecia areata provide an opportunity to create novel effective pharmaceutical interventions. The current lack of approved therapies for alopecia areata presents a high unmet medical need, as well as a potentially attractive market opportunity. From an industry perspective, achieving clinical proof of concept (PoC) gates investments into larger approval studies. Recent investigator-initiated experience suggests that it may be possible to demonstrate rigorous PoC for new therapies in an attractive time frame with relatively fewer patients than were believed necessary in the past. However, the lack of prior regulatory approval precedent for pharmaceuticals to treat alopecia areata poses significant development challenges, and early interaction with the FDA and other stakeholders will be critically important in evaluating the path to approval and reimbursement for new treatments for this indication. This paper presents a brief industry perspective on the potential development of new alopecia areata therapeutics.