18.05.2017 13:30:22
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Shire: Lanadelumab Phase 3 Study Meets Endpoints - Quick Facts
(RTTNews) - Shire plc (SHP.L, SHPG) announced positive topline Phase 3 results for the HELP study, a global double-blind placebo-controlled parallel group trial that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo over 26 weeks in patients 12 years of age or older with Hereditary Angioedema. The study met its primary endpoint and all secondary endpoints with highly statistically significant and clinically meaningful results for all three lanadelumab treatment arms compared to placebo. The 300 mg dose administered once every two weeks resulted in a statistically significant reduction in mean Hereditary Angioedema attack frequency of 87% compared to placebo.
The company said Lanadelumab was generally well tolerated over the 26-week treatment period. No treatment-related serious adverse events or deaths were reported.
Shire plans to submit a biologics license application (BLA) for evaluation by the U.S. FDA by late 2017 or early 2018.
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