RENEW OR SUBSCRIBE TO PPM
Subscription is FREE for qualified healthcare professionals in the US.

Alder BioPharmaceuticals Submits Biologics License Application for Eptinezumab

The CGRP-targeting drug would be the first quarterly infusion therapy for migraine prevention

A PPM Brief

Alder BioPharmaceuticals (Bothell, WA), announced1 the submission of a Biologics License Application (BLA) to FDA for eptinezumab, its investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP). Pending the submission’s acceptance and an FDA grants approval, the company announced that it will be on track for eptinezumab’s launch in Q1 2020.

Eptinezumab is backed by several global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in both chronic and episodic migraine prevention. The BLA application from Alder includes positive data from the company’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials, an open-label safety study, a pharmacokinetic comparability study, and chemistry, manufacturing, and controls data packages.

The CGRP-targeting drug would be the first quarterly infusion therapy for migraine prevention. (Source: 123RF)

“Completing the BLA submission of eptinezumab … underscores our continued mission to provide new treatment options for the millions of patients living with the debilitating effects of migraine,” said Bob Azelby, chief executive officer of Alder BioPharmaceuticals. “If approved, eptinezumab will be the first quarterly infusion therapy for migraine prevention designed specifically for rapid, effective, and sustained suppression of migraine.”

Results from the PROMISE clinical trials were presented at the 2018 American Association of Neurology and American Headache Society meetings and will soon be published in peer-reviewed publications, according to the company’s press release.

Eptinezumab from Alder joins these other CGRP-inhibitors currently approved:

  • erenumab-aooe (Aimovig, Amgen/Novartis), a receptor antagonist with a 28-day half-life; to be administered monthly at-home via subcutaneous injection; FDA approved Aimovig in May 2018, making it the first US-approved CGRP inhibitor for adult migraine prevention
  • fremanezumab (TEV-48125, Teva Pharmaceuticals), a ligand antagonist with an estimated 31- to 39-day half-life; to be administered monthly or quarterly via subcutaneous injection. FDA approved TEV-48125 in September 2018.
  • galcanezumab (LY2951742, Eli Lilly), a ligand antagonist with a 25- to 30-day half-life; to be administered monthly via subcutaneous injection. FDA approved Emgality in September 2018.
Last updated on: April 1, 2019
Continue Reading:
A New Frontier in Migraine Management: Inside CGRP Inhibitors & Migraine Prevention
close X
SHOW MAIN MENU
SHOW SUB MENU