Danish CNS specialist Lundbeck (LUND: CO) has announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a Phase III pivotal clinical trial predominantly conducted in Asia evaluating the efficacy and safety in patients with chronic migraine.
Based on the trial results Lundbeck plans to initiate discussions with relevant regulatory authorities with the aim of making Vyepti available for people suffering from migraine across Asia. Vyepti is already approved for migraine prevention in a number of countries including the USA and Europe.
In the SUNRISEtrial, Vyepti met the primary endpoint showing statistically significant reductions in monthly migraine days (MMD) as compared with placebo. From baseline (average of 17 days) over weeks 1 through 12, mean reductions in MMDs were -7.5 for 300mg and -7.2 for 100mg compared to -4.8 days for placebo (p<0.0001 and p<0.0001 for 300mg and 100 mg versus placebo, respectively).
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