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The U.S. Food and Drug administration has accepted the Biologics License Application for tralokinumab (LEO Pharma) for moderate-to-severe atopic dermatitis and is expected to make a decision in the second quarter of 2021.
A novel biologic is gaining traction with the recent announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for tralokinumab (Leo Pharma) for treatment of moderate-to-severe atopic dermatitis (AD) in adults.1
The BLA acceptance follows published positive results from three phase 3 clinical studies (ECZTRA 1, 2 and 3) that investigated efficacy and safety. Tralokinumab, which is a fully human monoclonal antibody, works by offsetting the interleukin-13 (IL-13) cytokine, which is believed to be one of the main contributors of inflammation in AD.
Of the three studies, ECZTRA 1 and 2 were randomized, double-blind, multinational, placebo-controlled, 52-week trials assessing tralokinumab 300 mg as a monotherapy among 802 and 794 adult patients, respectively, with moderate-to-severe AD who were eligible for systemic therapy. ECZTRA 3 was a placebo-controlled, double-blind, randomized, multinational, 32-week trial evaluating the same dose of tralokinumab but as a combination therapy with topical corticosteroids (TCS) in 380 adult patients with moderate-to-severe AD who were eligible for systematic therapy.2
As previously reported by Dermatology Times, results showed all primary and secondary endpoints were met across all three trials, including an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) at week 16 and a minimum change from the baseline of 75% or greater at week 16. The secondary endpoints include a change from the baseline in week 16 in SCORing of AD (SCORAD), Pruritis Numeric Rating Scale (NRS) of 4 and Dermatology Life Quality Index (DLQI).2
“There is a significant unmet medical need for people whose moderate-to-severe atopic dermatitis remains uncontrolled,” says Kim Kjøller, M.D., executive vice president of global research and development at LEO Pharma. “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. We will continue to work closely with the FDA as they review this application.”
Most recently, the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for the biologic and is under review with the EMA’s Committee for Medicinal Products for Human Use (CHMP).3
According to the Prescription Drug User Fee Act (PDUFA), the FDA will make a decision on tralokinumab in the second quarter of 2021.
1. LEO Pharma announces U.S. Food and Drug Administration (FDA) acceptance of Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis. (2020, July 09). Retrieved July 09, 2020, from https://www.businesswire.com/news/home/20200709005412/en/LEO-Pharma-announces-U.S.-Food-Drug-Administration
2. Petronelli, M. (2019, December 16). Tralokinumab meets endpoints for all phase 3 studies. Retrieved July 09, 2020, from https://www.dermatologytimes.com/view/tralokinumab-meets-endpoints-all-phase-3-studies
3. Petronelli, M. (2020, June 12). EMA accepts marketing application for tralokinumab. Retrieved July 09, 2020, from https://www.dermatologytimes.com/view/ema-accepts-marketing-application-for-tralokinumab