FDA Grants Fast Track Status to Lebrikizumab for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Fast Track designation to lebrikizumab (Dermira Inc) for the treatment of moderate-to-severe atopic dermatitis.

Lebrikizumab is a novel humanized monoclonal antibody that selectively inhibits interleukin-13 (IL-13), specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling. IL-13 is believed to play a central role in atopic dermatitis.

The designation was based on data from a phase 2b dose-ranging study as well as 2 exploratory phase 2 clinical studies. The phase 2b, double-blind, placebo-controlled study evaluated the safety and efficacy of lebrikizumab as monotherapy in 280 adults with moderate-to-severe atopic dermatitis. Patients were randomized to 3 different lebrikizumab dosing arms (125mg subcutaneous [SC] injection every 4 weeks, 250mg SC every 2 or 4 weeks) or placebo.

Results showed each of the lebrikizumab doses was associated with statistically significant improvement in the primary end point (mean percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16). Improvements in EASI score were observed in 62.3% of patients treated with lebrikizumab 125mg every 4 weeks (P =.0165), 69.2% of patients treated with lebrikizumab 250mg every 4 weeks (P =.0022), and 72.1% of patients treated with lebrikizumab 250mg every 2 weeks (P =.0005), compared with 41.1% of patients receiving placebo. 

With regard to safety, the most common adverse reactions reported were upper respiratory tract infection, nasopharyngitis, headache and injection site pain. 

“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,” said Tom Wiggans, chairman and chief executive officer of Dermira. “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.”

The Company is currently evaluating the safety and efficacy of lebrikizumab in two phase 3 studies, ADvocate 1 and ADvocate 2, in patients aged 12 years and older with moderate-to-severe atopic dermatitis.

For more information visit dermira.com.