Concert Pharmaceuticals, Inc. (CNCE) today announced that, after a recent review of deuruxolitinib clinical data by the U.S. Food and Drug Administration (FDA), the FDA determined that deuruxolitinib will maintain its Breakthrough Therapy designation. Deuruxolitinib, an oral Janus kinase (JAK) inhibitor, is being developed for the treatment of adult patients with moderate to severe alopecia areata.
In light of the FDA approval of a different JAK inhibitor as the first treatment for alopecia areata, the FDA previously notified Concert that it was reviewing the Breakthrough Therapy designation previously granted for deuruxolitinib. At the FDA’s request, Concert submitted additional clinical data and justification to support the continued eligibility of deuruxolitinib for the designation. The FDA has now informed Concert that, after reviewing these data, the Breakthrough Therapy designation criteria continue to be met at this time.
The FDA grants Breakthrough Therapy designation for drug candidates that treat a serious or life-threatening condition where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. Whether the improvement over available therapy is substantial is a matter of judgment and depends on both the magnitude of the treatment effect, which could include duration of the effect, and the importance of the observed clinical outcome. In general, the preliminary clinical evidence should show a clear advantage over available therapy.
The FDA originally granted Breakthrough Therapy designation to deuruxolitinib for the treatment of adult patients with moderate to severe alopecia areata in 2020, which was supported by positive data from a Phase 2 clinical trial. The additional information that Concert submitted to support the continued maintenance of the Breakthrough Therapy designation for deuruxolitinib included the positive data from two Phase 3 clinical trials.
About Deuruxolitinib and Alopecia Areata
Deuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. In addition to Breakthrough Therapy designation for the treatment of adult patients with moderate to severe alopecia areata, the FDA has granted deuruxolitinib Fast Track designation for the treatment of alopecia areata.
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to approximately 1.5 million Americans at any given time.1 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited treatment options available for alopecia areata.
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