30 November 2018 - Takhzyro is the first monoclonal antibody for the preventive treatment of Hereditary Angioedema in patients 12 years and older available in the European Union.

Shire today announced that the European Commission has granted Marketing Authorisation for Takhzyro (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. Takhzyro is a first-of-its-kind fully human monoclonal antibody that inhibits the activity of plasma kallikrein, an enzyme which is uncontrolled in people with HAE, to help prevent attacks. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of oedema (swelling) in various parts of the body.

The Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study supporting the approval was recently published in JAMA.

Read Shire press release