Shots:

• The approval follows P-III trials (PROMISE-1 in episodic migraine & PROMISE-2 in chronic migraine) assessing Vyepti vs PBO in 2-076 adult patients for the preventive treatment of migraine who have at least 4 migraine days/mos.
• The studies met its 1EPs of decrease in mean monthly migraine days (MMD) over 1-12wks and showed 50% & 75% responder rates & good tolerability
• Vyepti is a humanized mAb that binds to calcitonin gene-related peptide (CGRP)

 ­ Ref: PRNewswire | Image: Lundback