Shire Gets Euro OK for Preventive Treatment of Hereditary Angioedema

Shire Receives European Approval for TAKHZYRO™ (lanadelumab) subcutaneous injection, for the Preventive Treatment of Hereditary Angioedema

–       TAKHZYRO is the first monoclonal antibody for the preventive treatment of Hereditary Angioedema (HAE) in patients 12 years and older available in the European Union
–       In the pivotal study, patients taking TAKHZYRO 300 mg every two weeks had an 87% relative reduction in mean monthly attacks vs. placebo (0.26 vs. 1.97, n=27 vs. n=41)
–       All secondary endpoints (including relative reduction in the number of attacks requiring acute treatment or assessed as moderate or severe) were met
–       According to a post-hoc sensitivity analysis, 77% of patients receiving lanadelumab 300 mg every two weeks were attack-free during the steady-state period of the study

Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the European Commission (EC) 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 (mAb) 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.

https://www.marketscreener.com/SHIRE-9590198/news/Shire-Receives-European-Approval-for-TAKHZYRO-trade-lanadelumab-subcutaneous-injection-for-the-27684875/