Shire Granted Marketing Authorisation In EU For TAKHZYRO - Quick Facts

(RTTNews) - Shire plc (SHP.L, SHPG) announced the European Commission (EC) has granted Marketing Authorisation for TAKHZYRO (lanadelumab) subcutaneous injection, for routine prevention of recurrent attacks of hereditary angioedema in patients aged 12 years and older. Orphan Drug Designation has been maintained by the European Commission.

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 hereditary angioedema, to help prevent attacks.

TAKHZYRO also received approval for the prevention of hereditary angioedema attacks in people 12 years of age and older in the U.S. on 23 August 2018 and Canada on 19 September 2018.