MHLW (Japan) approves Takhzyro to prevent acute attacks of hereditary angioedema.
Takeda announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) for Takhzyro (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan.
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful. Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.. HAE affects an estimated 1 in 50,000 people worldwide. 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 in the country.
This approval is primarily based on results of the global Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study and the Phase III HELP Study Open-label Extension (OLE), in addition to results of a Phase III study evaluating the efficacy and safety of Takhzyro in Japanese patients. Combined, these studies have demonstrated the efficacy and safety profile of Takhzyro as a preventive treatment for HAE attack.