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FDA Accepts Alder BioPharmaceuticals' BLA for Eptinezumab

February 27, 2019
Another CGRP-targeting drug, offering quarterly infusions, will enter the market for episodic and chronic migraine prevention.

A PPM Brief 

Alder BioPharmaceuticals (Bothell, WA), announced FDA's acceptance of its Biologics License Application (BLA) for eptinezumab, its investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP). 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 included 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)

Results from the PROMISE clinical trials were presented at the 2018 American Association of Neurology and American Headache Society meetings. In the PROMISE 1 study, which focused on episodic migraine prevention, randomized patients (n=888) received eptinezumab (300 mg, 100 mg or 30 mg) or placebo, administered by infusion once every 12 weeks. Data showed that efficacy improved at one year following the third and fourth eptinezumab infusions: one-third of patients had no migraine attacks, achieving 100% reduction of monthly migraine days.

 

The PROMISE 2 trial focused on chronic migraine prevention. Randomized patients (n=1,072) receiving eptinezumab (300 mg or 100 mg) or placebo, administered by infusion once every 12 weeks. Data showed efficacy following the first and second infusions after six months. Patients experienced a reduction of approximately 9 monthly migraine days from baseline following the second quarterly infusion of eptinezumab, and one in five patients were migraine free (100% response) on average per month.

 

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.

“Migraine is far more than a headache, it’s a serious neurological disease with a debilitating impact to patients that can lead to other issues including depression, anxiety, and sleep disturbances," said Bob Azelby, Alder’s president and chief executive officer, in an April 2019 company release. “The FDA’s acceptance of our BLA is an important milestone, and the company remains focused on supporting the application review for the first quarterly infusion therapy for patients suffering from episodic and chronic migraine."

 

 

Updated April 23, 2019.

 

Last updated on: April 25, 2019
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