Will This FDA Decision Set Off These Late-Stage Dermatitis Studies?

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Dermira Inc. (NASDAQ: DERM) shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for lebrikizumab, its treatment being evaluated for patients with moderate-to-severe atopic dermatitis.

Some quick background: Fast Track is a designation granted by the FDA intended to facilitate the drug development process and expedite the review of therapies to treat serious conditions and fill an unmet medical need, including by demonstrating an advantage over currently available therapy.

The goal of the Fast Track process is to ensure important new treatments reach patients as quickly as possible.

Lebrikizumab is being evaluated in two Phase 3 studies, ADvocate 1 and ADvocate 2, to confirm its safety and efficacy in adolescent and adult patients, ages 12 years and older, with moderate-to-severe atopic dermatitis.

Tom Wiggans, board chair and chief executive of Dermira, commented:

We are pleased that the FDA granted lebrikizumab its Fast Track designation and recognizes the unmet need for patients living with moderate-to severe atopic dermatitis and the potential for lebrikizumab to offer a treatment for this serious condition. This Fast Track designation puts us one step closer to potentially delivering a new therapeutic option more quickly to patients should the results from earlier Phase 2 studies be confirmed in the ongoing Phase 3 studies assessing the safety, efficacy and tolerability of the investigational therapy.

Shares of Dermira traded up about 12% to $10.22 Tuesday morning, in a 52-week range of $5.25 to $15.48. The consensus price target is $22.67.


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