Lundbeck’s Vyepti (eptinezumab-jjmr) Receives the US FDA’s Approval to Prevent Migraine in Adults

 Lundbeck’s Vyepti (eptinezumab-jjmr) Receives the US FDA’s Approval to Prevent Migraine in Adults

Shots:

  • The approval is based on two P-IIItrials PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine  involves assessing of Vyepti (100mg or 300mg) vsPBO in 2076 patients with migraine
  • PROMISE 1 study results: mean migraine frequency ~8.6 migraine days/month, mean change in MMD in 1-3mos. @100mg or 300mg  (-3.9 days, -4.3 days vs -3.2 days), Responders with at least 50% & 75% reduction in MMD in 1-3mos. (49.8% & 22.2%, 56.3% & 29.7% vs 37.4%, 16.2%), greater patients had migraine @first 7 days vs PBO
  •  PROMISE 2 study: Mean migraine frequency ~ 16.1 migraine days/month, mean change in MMD in 1-3mos. @@100mg or 300mg (-7.7 days, -8.2 days vs -5.6 days), Responders with at least 50% & 75% reduction in MMD in 1-3 mos. (57.6% & 26.7%, 61.4% & 33.1% vs 39.3%, 15.0%)
  • Vyepti is mAb that binds to calcitonin gene-related peptide (CGRP) ligand further blocking the binding to receptors. The company has also submitted marketing application in Canada with expected submission to EU in 2020

Click here to read full press release/ article | Ref: Lundbeck | Image: Pharma World

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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