Leo Pharma's Adtralza Gets Nod or Adults with AD in Japan
Adtralza / Adbry (tralokinumab-ldrm) is approved for the treatment of adults with moderate-to-severe AD in the European Union, United States, Great Britain, Canada, the United Arab Emirates, and Switzerland.
The Japan Ministry of Health, Labor and Welfare has granted approval for the manufacturing and marketing of LEO Pharma’s Adtralza (tralokinumab) subcutaneous injection for adults with atopic dermatitis, which has inadequately responded to conventional therapies.
“Today’s approval is a significant advancement for those patients in Japan who continue to suffer from the often-debilitating symptoms of atopic dermatitis and are in need of a new treatment option to manage their chronic condition,” says Kook Hyun Son, General Manager of LEO Pharma K.K, in a news release. “We have made substantial investments in our infrastructure, including the hiring of dedicated medical staff to ensure dermatologists receive the latest Adtralza clinical information to help inform treatment decisions for their patients.”
Adtralza is the first and only approved human, monoclonal antibody developed to specifically target and neutralize the IL-13 cytokine, which plays a key role in the immune and inflammatory process which are the underlying causes of atopic dermatitis signs and symptoms. The Ministry has approved Adtralza to be administered as a subcutaneous injection in adults with an initial dose of 600mg, followed by a 300mg dose given every other week.
“The Japan approval is a demonstration of our strategy to expand the availability of Adtralza to millions of patients around the world who are faced with the daily challenges of living with chronic and often debilitating symptoms of atopic dermatitis,” adds Becki Morison, executive vice president of global strategy and international operations, LEO Pharma A/S. “We continue to evaluate regulatory filings in markets where there is the greatest need to help ensure patients who may benefit from Adtralza will have access to this biologic therapy.”
The approval is based on results from the global pivotal trials ECZTRA 1, 2, and 3, the Japanese pivotal trial ECZTRA 8, and the global open-label extension trial ECZTEND.
About the ECZTRA 8 trial
ECZTRA 8 was a 16-week, double-blind, randomized, placebo-controlled phase 3 study in Japanese patients. The study evaluated the efficacy and safety of tralokinumab (300 mg) in combination with TCS in 106 adult patients with atopic dermatitis who were candidates for systemic therapy having an inadequate response to existing therapy.
About the ECZTEND - long-term extension (LTE) trial
ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous tralokinumab Trials) is an ongoing Phase 3, long-term five-year, open-label, single-armextension trial to evaluate the efficacy and safety of tralokinumab in patients with atopic dermatitis who participated in the previous tralokinumab monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy tralokinumab plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with tralokinumab or placebo.