Phase III HELP study of Takhzyro shows reduction in attacks of hereditary angioedema.- Shire.

Shire announced additional data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study, evaluating the efficacy and safety of subcutaneously administered Takhzyro (lanadelumab) in Hereditary Angioedema (HAE) which showed that patients treated with lanadelumab 300 mg every two weeks experienced significantly fewer HAE attacks, were less likely to have moderate or severe attacks or use rescue medication (primary and secondary endpoints), and were more likely to be HAE attack-free than those treated with placebo. These results were noted during the entire 26-week treatment period and, according to a post hoc sensitivity analysis, were greatest for patients during the 16-week steady state period (days 70-182).

Interim results from the HELP Study open-label extension found treatment with lanadelumab was generally well-tolerated and consistent with the previously observed safety profile. The most commonly reported adverse events, excluding events related to HAE attacks, were injection site pain (42.9%), followed by upper respiratory infection (23.8%), headache (20.2%) and injection site erythema (9.5%). At the time of interim analysis, patients had been exposed to lanadelumab for a mean (SD) of 8.21 (2.17) months and continued to experience a reduction in HAE attacks. Data was presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2018 Annual Scientific Meeting.