TAKHZYRO (lanadelumab) - Prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older

The clinical benefit of TAKHZYRO (lanadelumab) remains substantial in the indication “prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older”.

Considering:

• experience relative to the safety of lanadelumab, with, in particular, the final results of the extension study after 30 months of follow-up and the absence of any identified safety signals,
• new, exploratory efficacy data, which appear to support the benefit of lanadelumab used preventively to reduce the number of attacks,
• the absence of robust comparative data versus the alternatives containing a human plasma-derived C1-esterase inhibitor or berotralstat, with available data obtained from indirect comparisons presenting numerous methodological limitations not enabling their results to be taken into account,
• the absence of new clinical findings liable to modify the initial assessment,   

the Committee considers that TAHKZYRO (lanadelumab) maintains a minor clinical added value (CAV IV) as long-term preventive background treatment in patients aged 12 years and older.