Alder BioPharmaceuticals Reports FDA’s Acceptance of BLA for Eptinezumab to Prevent Migraine

 Alder BioPharmaceuticals Reports FDA’s Acceptance of BLA for Eptinezumab to Prevent Migraine

Alder BioPharmaceuticals Reports FDA’s Acceptance of BLA for Eptinezumab to Prevent Migraine

Shots:

  • The BLA submission is based on P-III PROMISE 1 & 2 studies results assessing Eptinezumab (300,100/30 mg & 300/100 mg) vs PBO in 888 & 1,072 patients with episodic & chronic migraine experiencing 14 & 15 headache days/mos. of which 4 & 8 met the criteria for migraine respectively
  • The P-III PROMISE 1 & 2 studies result: met 1EPs & 2Eps; @12wks. change in monthly migraine days; responder rates at least 75% & 50%; reduction in migraine prevalence days 1-28, at least 50%,75%,100%; change in mean monthly acute migraine medication days; reductions in patient-reported impact scores on the Headache Impact Test (HIT-6)
  • Eptinezumab (IV, q12w) is a mAb targeting the calcitonin gene-related peptide (CGRP) indicated for the prevention of migraine. Alder has submitted its BLA on Feb 21,2019 with expected PDUFA action date within 74 days post submission and plans to launch it in Q1’20

Click here to read full press release/ article | Ref: Alder BioPharmaceuticals | Image: Pinterest

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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