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

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

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  • 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

Ref: Alder BioPharmaceuticals | Image: Pinterest

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