Dermira announced Tuesday that the FDA granted a fast-track designation to lebrikizumab for the treatment of patients with moderate-to-severe atopic dermatitis. Shares in the drugmaker were up as much as 12% on the news.
"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 II studies be confirmed in the ongoing Phase III studies," remarked CEO Tom Wiggans.
The monoclonal antibody designed to bind IL-13 is currently being evaluated in the late-stage ADvocate 1 and ADvocate 2 trials in patients ages 12 years and older with moderate-to-severe atopic dermatitis. Earlier this year, the company reported Phase II results showing that lebrikizumab significantly improved symptoms versus placebo in adults with the condition.
Dermira licensed the drug from Roche in 2017 for development in atopic dermatitis and other indications under a deal potentially worth more than $1.4 billion.
For related analysis, read ViewPoints: Investors reward Dermira for injection of confidence on lebrikizumab.
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