European Commission approves Takhzyro subcutaneous injection, for the preventive treatment of hereditary angioedema.- Shire/Takeda

Shire plc 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.The recommended starting dose is 300 mg lanadelumab every two weeks. In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every four weeks may be considered, especially in patients with low weight.

The Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study supporting the approval was recently published in JAMA. The primary endpoint was the number of investigator-confirmed HAE attacks over the entire 26-week study duration. Takhryro reduced the mean number of monthly HAE attacks by 87% relative to placebo when administered at 300 mg every two weeks and 73% relative to placebo when administered at 300 mg every four weeks (adjusted P<0.001).>

Comment: Takhzyro also received approval for the prevention of HAE attacks in people 12 years of age and older in the U.S. on 23 August 2018 and Canada on 19 September 2018.