Shire plc has announced additional data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study, evaluating the efficacy and safety of subcutaneously administered Lanadelumab in HAE.
Data shows 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).
Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire said, “For those living with this chronic and unpredictable disease, it is important that they can reduce the frequency of their HAE attacks. Additional analysis of the HELP Study continues to support the use of Lanadelumab as a preventive subcutaneous treatment option for HAE in appropriate patients 12 years of age and older.”
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. 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.
“The data we have seen from the HELP open-label extension are very promising and we look forward to receiving the final results,” said Dr. Busch.