Takeda posts positive Ph III results for Takhzyro in patients with hereditary angioedema

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) today announced the final results from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE), showing that Takhzyro (lanadelumab-flyo) helped prevent and reduce the frequency of hereditary angioedema (HAE) attacks long term in patients 12 years of age and older who received treatment for a mean (standard deviation) duration of 29.6 (8.2) months.

Results were consistent with the safety and efficacy of Takhzyro in the pivotal trial. The mean (min, max) HAE attack rate was reduced by 87.4% (-100; 852.8) overall versus baseline (N=212) and in a pre-specified exploratory endpoint, nearly 70% (68.9%) of patients treated with Takhzyro 300mg every two weeks experienced an attack-free period of more than 12 months (n=209). The data are being presented at the 2020 American College of Allergy, Asthma and Immunology (ACAAI) Virtual Annual Scientific Meeting and will also be published in the November issue of ACAAI’s journal Annals of Allergy, Asthma & Immunology.

Takhzyro was originated by Dyax Corp before being picked up in 2016 for $5.9 billion by rare disease specialist Shire, which in turn was acquired by Takeda, in a $62 billion deal that completed in 2019.