Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
April 24, 2019

Teva stops fremanezumab development in cluster headache

Teva Pharmaceutical has decided to suspend the ENFORCE Phase III clinical development programme of fremanezumab in cluster headache.

Teva Pharmaceutical has decided to suspend the ENFORCE Phase III clinical development programme of fremanezumab in cluster headache.

A futility analysis of a Phase III clinical trial for episodic cluster headache showed that the therapeutic is not likely to meet the primary endpoint of a mean change in the weekly average number of cluster headache attacks from baseline during the four-week treatment duration.

Based on the analysis of the results, Teva decided to suspend the clinical trial programme, which also includes a long-term safety study.

The programme also comprised a chronic cluster headache trial that was discontinued in June last year after a futility analysis found that the primary endpoint would not be met.

“Despite these results, we are continuing to evaluate if fremanezumab treatment can provide clinical benefits in additional diseases.”

However, Teva intends to continue developing fremanezumab in other indications. The compound is currently being assessed in a Phase II trial to treat post-traumatic headaches.

Teva Pharmaceutical Global Specialty Clinical Development head Tushar Shah said: “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.”

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

Fremanezumab is a humanised monoclonal antibody designed to bind to and prevent the calcitonin gene-related peptide (CGRP) ligand interaction with its receptor.

In September last year, the US Food and Drug Administration (FDA) approved the use of fremanezumab, under the brand name Ajovy, as a preventive treatment for migraine in adults.

The approval is based on data from two Phase III trials that assessed the drug as a stand-alone preventive therapy, as well as in combination with oral preventive treatments.

According to the results, patients had a decrease in monthly migraine days during a 12-week period.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU