Teva has announced an update on its Ajovy (fremanezumab) clinical development for use in episodic cluster headache, after a Phase III study found that the primary endpoint for weekly average number of cluster headache attacks during the four-week treatment period is unlikely to be met.
Due to the results, Teva has chosen to discontinue the ENFORCE Phase III trial, bad news for the company as the .S Food and Drug Administration (FDA) recently granted priority review to Eli Lilly's filing seeking clearance of Emgality for the preventive treatment of episodic cluster headache in adults.
Tushar Shah, senior vice president, head of Global Specialty Clinical Development at Teva, thanked “patients and investigators for their immense contributions to this study”, adding that “Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases where anti-calcitonin gene-related peptide (CGRP) therapy may play a role in its pathophysiology.”
The drug, which is a humanised monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, was recently given European Commission approval for migraine. It is considered an investigational compound in the treatment of cluster headache or post-traumatic headache and is not approved by any regulatory agency for those uses.
Revenue from Ajovy was just $3 million in 2018, but is expected to grow to $150 million this year.