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,” said Kook Hyun Son, General Manager of LEO Pharma K.K. “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.^1,2 The MHLW 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,” said 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,^3,4 the Japanese pivotal trial ECZTRA 8⁵, and the global open-label extension trial ECZTEND. ^6,7