Lilly Receives FDA Approval for Emgality (galcanezumab-gnlm) for Preventive Treatment of Migraine in Adults

Eli Lilly Reports Results of Lartruvo (olaratumab) in ANNOUNCE P-III Study for Advanced or Metastatic Soft Tissue Sarcoma (STS)

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  • Emgality’s approval is based on two P-III trials (N=425) (EVOLVE-1 and EVOLVE-2) and one P-III REGAIN trial (N=450) administering once monthly PBO vs Emgality 120 mg after an initial dose of 240 mg, or Emgality 240 mg, evaluating its safety and efficacy
  • P-III EVOLVE-1 & EVOLVE-2 Results: mean change from baseline days (4.7 vs -2.8) & (4.3 vs-2.3), @50% reduction in migraine headache days (MHDs) (62% vs 39%)& (59% vs 36%), @75% in MHD (39% vs 19%) & (34% vs 18%), @100% MHD (16% vs 6%) & (12% vs 6%); REGAIN Results: mean change from baseline days (4.8 vs -2.7), @50% MHD (28% vs 15%)
  • Emgality IV self-administered recommended dose is 240 mg (two consecutive SC IV of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg. The US list price of Emgality is $575 once monthly, or $6,900 annually

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