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