Shots:

• 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

Ref: Lilly | Image: Market Exclusive