Takeda announced the European Commission has approved TAKHZYRO (lanadelumab) for the routine prevention of recurrent attacks of Hereditary Angioedema (HAE) in patients aged 2 years and older, expanding its initial approved use and making it the first long-term prophylactic treatment of HAE available in European Economic Area for patients under the age of 6.
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The recently approved extension of the indication in paediatric patients was paired with an additional strength of 150 mg for Lanadelumab solution for injection in pre-filled syringe.
TAKHZYRO 150mg should be used in patients aged 2 years and older and weighing less than 40 kg to prevent angioedema attacks in patients with Hereditary Angioedema (HAE).
Previously indicated for the routine prevention of recurrent attacks of HAE in patients aged 12 years and older in the EEA5, the update is supported by clinical data from Phase 3 Study SHP643-3016, in combination with extrapolation of data from the pivotal Adult and Adolescent Study DX-2930-037, and by quality data supporting the new 150 mg pre-filled syringe formulation.
Overall, the safety and efficacy of TAKHZYRO in preventing Hereditary Angioedema (HAE) attacks in paediatric patients aged 2 and above was demonstrated and the benefit risk-balance was considered positive.
The EMA is the second Agency recommending approval in paediatric population 2 years of age and older, following the U.S. Food and Drug Administration's (FDA) approval of the supplemental Biologics License Application (sBLA) in February this year, for the same expanded use of TAKHZYRO (lanadelumab-flyo).
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.
The swelling can be debilitating and painful. Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.12 HAE affects an estimated 1 in 50,000 people worldwide.13 It is often under recognised, under diagnosed and under treated.
HAE, like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. ■