Takeda (TSE:4502/NYSE:TAK) has received approval from Japanese regulatory authorities for subcutaneous injection of the monoclonal antibody Takhzyro (lanadelumab) as a prophylaxis against acute attacks of hereditary angioedema (HAE) in individuals at least 12 years old.
HAE involves recurring episodes of severe (angioedema) in various body parts such as the abdomen, limbs, face, intestinal tract, genitals, hands and throat.
Attacks affecting the airways can be potentially life-threatening.
The drug’s approval in Japan was based on data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase 3 HELP Study Open-label Extension (OLE).
Takeda also submitted results from a Phase 3 study evaluating the efficacy and safety of Takhzyro in Japanese patients. In that study, 41.7% of the Takhzyro recipients did not have attacks during the 26-week evaluation period following subcutaneous administration of Takhzyro once every two weeks.
“In addition to the burden of debilitating and potentially life-threatening HAE attacks, the unpredictable nature of this disease presents significant challenges to patients and their support networks,” said Naoyoshi Hirota, general manager, Takeda Development Center, Japan, in a statement.
“We hope Takhzyro, a new treatment option for patients in Japan living with HAE, along with the efficacy and safety profile as a preventive treatment showcased across global studies and within a Japan-specific Phase 3 study, will contribute to HAE treatment.”
The drug was FDA approved for hereditary angioedema in 2018.
Prefilled syringe of Takhzyro for Hereditary Angioedema Attacks won FDA approval in the U.S. in 2022.
Filed Under: Biologics