The European Commission Approves Label Update For TAKHZYRO, Expanding Its Use To A Broader Group Of Paediatric Patients With Recurrent Attacks Of Hereditary Angioedema
Portfolio Pulse from Benzinga Newsdesk
The European Commission has approved an expanded use of Takeda's TAKHZYRO (lanadelumab) for routine prevention of Hereditary Angioedema (HAE) in patients aged 2 years and older, making it the first long-term prophylactic HAE treatment in the EU for patients under six. The approval includes a new 150 mg strength for younger patients and is supported by clinical data from a Phase 3 study and extrapolation from an adult and adolescent study.
November 17, 2023 | 3:26 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Takeda's TAKHZYRO has been approved by the European Commission for use in paediatric patients aged 2 years and older for the prevention of HAE, potentially increasing the drug's market and revenue in the EU.
The approval of TAKHZYRO for a broader paediatric population in the EU is a significant development for Takeda, likely leading to increased usage and sales. As the first long-term prophylactic HAE treatment for patients under six, TAKHZYRO may see a competitive advantage in the market. The positive clinical data and the FDA's prior approval for the same use in the US further support the potential for a favorable market reception.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100