The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for tralokinumab (Leo Pharma) for the treatment of adults with moderate to severe atopic dermatitis (AD).
Tralokinumab is a fully human, immunoglobulin (Ig) G4 monoclonal antibody that works by specifically binding to the interleukin-13 (IL-13) cytokine with high affinity and preventing its interaction with subsequent downstream signalling.
The BLA submission is supported by data from the 3 pivotal, double-blind, placebo-controlled phase 3 (ECZTRA 1-3) studies that evaluated the safety and efficacy of tralokinumab in adults with moderate to severe AD. ECZTRA 1 and ECZTRA 2 assessed tralokinumab as monotherapy in 802 and 794 adults, respectively, for 52 weeks. ECZTRA 3 assessed tralokinumab in combination with topical corticosteroids in 380 adults for 32 weeks.
The primary end points for all 3 studies were an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16 and at least a 75% or greater change from baseline in the Eczema Area and Severity Index (EASI) score at week 16. Secondary end points included change from baseline in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI).
Results from all 3 studies showed tralokinumab met all primary and secondary end points. Regarding safety, tralokinumab showed an overall adverse event rate that was comparable to placebo.
A Prescription Drug User Fee Act (PDUFA) action date for the second quarter of 2021 has been set for this application.
“If approved, tralokinumab could become the first biologic available to specifically neutralize the IL-13 cytokine and, most importantly, offer a more targeted approach for adults living with this debilitating disease,” said Kim Kjøller, MD, Executive Vice President, Global Research and Development, LEO Pharma. “We will continue to work closely with the FDA as they review this application.”
For more information visit leo-pharma.com.