Policy & Regulation
US FDA grants Dermira's lebrikizumab fast track designation
12 December 2019 -

The US Food and Drug Administration (FDA) has granted United States-based Dermira fast track designation for its lebrikizumab intended for the treatment of moderate-to-severe atopic dermatitis, it was reported yesterday.

According to the company, the product is a monoclonal antibody that can bind with very high affinity with the Interleukin 13 (IL-13) cykotine. Through this mechanism, the antibody is said to specifically inhibit the formation of the IL-13R alpha 1/IL-4R alpha heterodimer complex and subsequent signalling to block the biological effects of IL-13 in a targeted and efficient manner. The investigational drug was previously evaluated in two phase 2 clinical trials – TREBLE and ARBAN.

In the TREBLE study, the IL-13 inhibitor was assessed for its safety and efficacy in combination with topical corticosteroids, while the ARBAN study evaluated it as a monotherapy. Dermira said that in both the mid-stage studies, data suggested clinical improvements in patients treated with the IL-13 inhibitor.

Dermira chairman and CEO Tom Wiggans said, 'We are pleased that the FDA granted lebrikizumab its Fast Track designation and recognises 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.'