EMA Recommends mAb for Treatment of Hereditary Angioedema

October 23, 2018

Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

On October 19, 2018, the European Medicines Agency (EMA) announced it had granted marketing authorization to Takhzyro (lanadelumab). The biologic is the first monoclonal antibody therapy (mAb) for the treatment of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

HAE is a rare, long-term debilitating disease caused by abnormalities in the gene responsible for the production of C1 esterase inhibitor. Patients with HAE experience swelling beneath the skin that can occur anywhere in the body including the limbs, gut, larynx, and face. Swelling in the larynx may be life threatening. According to EMA, Takhzyro (lanadelumab) recognizes and attaches to kallikrein proteins, blocking the activity of the kallikrein-kinin system and reducing the number of angioedema attacks.

EMA’s Committee for Medicinal Products for Human Use determined that Takhzyro, which is administered subcutaneously every two to four weeks, improves patient care compared to current therapies that are administered either intravenously or more frequently. The committee, therefore, agreed to accelerated assessment and recommendation of this medicine.

Source: EMA