Novartis Says CGRP Migraine Blocker Shows Good Results in Late-Stage Study

January 23, 2018

Novartis' calcitonin gene-related peptide (CGRP) inhibitor for prevention of migraine, erenumab, showed positive results in a phase 3b study in episodic migraine patients who have failed multiple prior preventive treatments.

Novartis' calcitonin gene-related peptide (CGRP) inhibitor for prevention of migraine, erenumab, showed positive results in a phase 3b study in episodic migraine patients who have failed multiple prior preventive treatments.

Erenumab (AMG 334) achieved at least a 50% reduction of migraine days versus placebo, and all secondary endpoints, including:

  • reduction of monthly migraine days
  • reduction in days needing rescue medication
  • improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool
  • and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo)

The monoclonal antibody is currently under FDA review. If approved, it will be administered once-monthly using a self-injection device.

Novartis and Amgen will co-commercialize erenumab in the US. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.

The Institute for Clinical and Economic Review (ICER) is reviewing erenumab and other CGRPs for clinical effectiveness and value. The analysis is expected later this year.