Takeda files Japan NDA for lanadelumab for HAE

Takeda Pharmaceutical (TYO: 4502) has submitted a New Drug Application (NDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for Takhzyro (lanadelumab) subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. 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 about 450 have been diagnosed due to low awareness of the disorder in the country.

Takhzyro received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 and the drug is now available in more than 20 countries with additional regulatory submissions ongoing worldwide.

For the first nine months of Takeda’s current fiscal year, the drug – which came into Takeda’s hands with the $62 billion acquisition of Shire - generated sales of 65.9 billion yen ($610 million), up 38% on the like year-earlier period.