The U.S. FDA has granted Dermira with a Fast Track designation for its atopic dermatitis drug lebrikizumab following the start of phase 3 clinical trials to examine the efficacy, tolerability and safety of the drug.
A new therapy for atopic dermatitis (AD) is gaining momentum with a recent announcement from the United States Food and Drug Administration.
The U.S. FDA granted Dermira’s AD treatment, lebrikizumab, with a Fast Track designation on Dec. 10. A Fast Track designation is issued by the FDA to accelerate the development and review process of drugs in order to quickly deliver new therapies to individuals.
Lebrikizumab is a monoclonal antibody IL-13 inhibitor that binds Interleukin-13 to prevent formation and signaling of IL-13RÎ±1 and IL-4RÎ±. IL-13 is considered to be the pathogenesis of AD, stimulating infection, skin thickening, itch, skin barrier malfunction and inflammation.
“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,” says Tom Wiggans, chairman and chief executive officer of Dermira.
Lebrikizumab is presently undergoing two phase 3 studies, ADvocate 1 and ADvocate 2, examining the efficacy and safety of the drug on nearly 800 moderate-to-severe AD patients 12 years and older.
Participants are required to have an Investigator’s Global Assessment (IGA) score of 3 or 4, a minimum body surface area (BSA) involvement of 10% at baseline and an Eczema Area Severity Index (EASI) score of 16 or higher.
In the current clinical trial, patients are given 250 mg of lebrikizumab by subcutaneous injection every two weeks after an initial 500 mg injected dose at baseline and week two. Researchers are observing the effects of the drug compared to a placebo for the 16-week long induction period.
Results of the phase 3, 16-week induction period are expected in early 2021.
Thereafter, participants who respond well to the treatment will be re-randomized and placed into one of three treatment groups for an extra 36-week period.
“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,” states Wiggans.
Dermira is also planning an additional phase 3 study to examine how lebrikizumab interacts in conjunction with a topical corticosteroid.