dm+d

Unassigned

New Medicines

Takhzyro Routine prevention of recurrent attacks of hereditary angioedema in patients aged 2-11 years

Information

Takhzyro
Licence extension / variation
Takeda
Dyax/ Shire

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

Fully human monoclonal antibody that inhibits plasma kallikrein (pKal)
The incidence is approximately 1 in 50,000 although there may be variation geographically. It can affect people of any ethnic group or gender. Usually it presents in childhood, with the mean age of onset being between 8 and 12 years [1].
Routine prevention of recurrent attacks of hereditary angioedema in patients aged 2-11 years
Subcutaneous injection

Takhzyro Non-histaminergic angioedema with normal C1 inhibitor including hereditary angioedema with normal C1 inhibitor (formerly type 3 HAE) and idiopathic non-histamine mediated angioedema

Information

Takhzyro
Licence extension / variation
Takeda
Dyax/ Shire

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fully human monoclonal antibody that inhibits plasma kallikrein (pKal)
The most common type of HAE is the result of impaired C1 inhibitor (C1-INH) activity. In 2000, a novel type was identified linked with normal C1-INH activity in plasma and classified as HAE with normal C1-INH (HAEnCI) or HAE type 3. Eight different HAE-specific mutations have been identified: 4 located in the F12 gene, and 4 in the PLG, ANGPT-1, KNG-1, and MYOF genes. Prevalence is highly variable: HAE-FXII in 185 families, HAE-PLG in 33 families, HAE-ANGPT1 and HAE-KNG1 in one family each [1].
Non-histaminergic angioedema with normal C1 inhibitor including hereditary angioedema with normal C1 inhibitor (formerly type 3 HAE) and idiopathic non-histamine mediated angioedema
Subcutaneous injection