EMA accepts marketing application for tralokinumab


LEO Pharma will soon begin marketing its monoclonal antibody tralokinumab for atopic dermatitis with the announcement that the EMA has accepted the marketing authorization application for the drug.

LEO Pharma announced that the marketing authorization application (MAA) for tralokinumab was accepted by the European Medicines Agency (EMA).1 The EMA will now begin the review process for this investigative atopic dermatitis (AD) treatment through the Committee for Medicinal Products for Human Use (CHMP).1

Tralokinumab is a monoclonal antibody that works to offset the interleukin-13 (IL-13) cytokine, which is believed to be one of the main contributors of inflammation in AD.

“People living with atopic dermatitis often face tremendous physical, social and emotional challenges,” says Kim Kjøller, M.D., executive vice president of global research and development at LEO Pharma. “Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden. We look forward to working closely with the EMA as they review this application.”

MORE: Tralokinumab meets endpoints for all phase 3 studies

The MAA acceptance is supported by positive results from LEO Pharma’s three phase 3 studies (ECZTRA 1, 2 and 3) which investigated the safety and efficacy of tralokinumab.

ECZTRA 1 and 2 were double-blind, randomized, multinational, placebo-controlled, 52-week trials evaluating tralokinumab 300mg as a monotherapy in 802 and 794 moderate-severe AD patients who were eligible for systemic therapy.

Meanwhile, ECZTRA 3 was a randomized, placebo-controlled, double-blind, multinational, 32-week trial investigating tralokinumab 300 mg as a combination therapy with topical corticosteroids (TCS) in 380 patients with moderate-to-severe AD who were eligible for systemic therapy.

All three studies met primary and secondary endpoints, which included 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 a Dermatology Life Quality Index (DLQI), as previously reported by Dermatology Times.2


1. LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab for the Treatment of Adults With Moderate-To-Severe Atopic Dermatitis. (2020, June 11). Retrieved June 15, 2020, from https://www.businesswire.com/news/home/20200611005397/en/LEO-Pharma-Announces-European-Medicines-Agency-Acceptance

2. Petronelli, M. (2019, December 16). Tralokinumab meets endpoints for all phase 3 studies. Retrieved June 15, 2020, from https://www.dermatologytimes.com/view/tralokinumab-meets-endpoints-all-phase-3-studies

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