Nachtzwaluw schreef op 11 september 2017 13:33:
Dit is pas nieuws:
Shire’s Investigational Subcutaneous C1 esterase inhibitor (C1 INH [Human]) Liquid for Injection (SHP616) Significantly Reduces Hereditary Angioedema Monthly Attack Rate Versus Placebo in a Phase 3 Pivotal Trial
• Median HAE attack reduction of 79% from Day 0 and 85% from Day 14
• 38% of patients HAE attack free while receiving SHP616
Lexington, MA – September 11, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, announces positive topline Phase 3 results for the SAHARA™ study, a global, multi-center, randomized, double-blind, placebo-controlled, partial crossover trial that evaluated the efficacy and safety of subcutaneously administered C1 esterase inhibitor [human] Liquid for Injection, also referred to as SHP616 Liquid, versus placebo over two 14-week treatment periods in patients 12 years of age or older with symptomatic Hereditary Angioedema (HAE). SHP616 is an investigational treatment administered subcutaneously, being evaluated for the prevention of angioedema attacks in patients with HAE—a rare genetic disease characterized by recurrent swelling of extremities, gastrointestinal tract, and upper airways.
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