Takeda Pharmaceutical Company Limited has submitted a New Drug Application to the Ministry of Health, Labour and Welfare in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of HAE.
In Japan, it is estimated that between 2,000 and 3,000 people are living with HAE, but only approximately 450 have been diagnosed due to low awareness of the disorder.
“Recognition of HAE remains low in Japan, meaning there are significant challenges relating to diagnosis and access to effective therapies,” says Naoyoshi Hirota, General Manager, Takeda Development Center, Japan. “Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.
The submission of the New Drug Application in Japan is primarily based on results of the global Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE), in addition to interim results of a Phase 3 study evaluating the efficacy and safety of lanadelumab in Japanese subjects. Combined, these studies have demonstrated the efficacy and safety profile of lanadelumab as a preventive treatment for HAE attacks. If approved, lanadelumab will be available to patients in Japan as a pre-filled syringe presentation.
The regulatory submission in Japan will be evaluated by the Japanese Pharmaceuticals and Medical Devices Agency. Following its review, the Agency will issue a report to the Ministry of Health, Labour and Welfare of Japan for a final decision.
Lanadelumab, under the tradename Takhzyro, received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 and is now available in more than 20 countries with additional regulatory submissions ongoing worldwide.