Teva Pharmaceuticals has a new headache. As the Israel-based company pushes forward with its cost-cutting strategies, the company reported it is scrapping its chronic cluster headache program with fremanezumab following a pre-specified futility analysis of that study.
This morning the Israel-based company announced the analysis revealed the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. There were no safety concerns with the CGRP inhibitor. With the disappointing news in hand, Teva said it will discontinue the chronic cluster headache trial. A long-term safety study in chronic cluster headaches with fremanezumab will also be discontinued, Teva said.
Cluster headaches are excruciating headaches that typically occur for a long period of time, a week to a year. That is then followed by a pain-free period. Chronic cluster headaches can continue for longer than a year, or the remission period is much shorter than typical cluster headaches, according to the Mayo Clinic. Cluster headaches are considered to be the most severe form of recurrent pain.
A study testing fremanezumab in episodic cluster headache is not affected. That trial will continue.
“While we are disappointed with this outcome, we remain optimistic that fremanezumab could have clinical benefits in additional conditions, beyond migraine, where calcitonin gene-related peptide (CGRP) plays a contributory role in their pathophysiology,” Tushar Shah, head of Global Specialty Clinical Development at Teva said in a statement.
Teva’s stock is down slightly on the news this morning, trading at $23.66 as of 11:02 a.m.
Calcitonin gene-related peptide (CGRP) is a popular target for the treatment of migraine and chronic headaches. In December Ernesto Aycardi, the head of migraine and headache R&D at Teva, told BioSpace that the importance of CGRP in migraine studies is not to be missed.
Multiple companies are focusing their resources on the development of anti-CGRP treatments for headaches. Amgen and Novartis AG are set to launch Aimovig, its CGRP inhibitor that was approved by the U.S. Food and Drug Administration in May. The migraine medication was approved based off of stunning Phase III data that showed Aimovig reduced monthly migraine attacks in half. Teva is expecting the FDA to make a decision on fremanezumab as a migraine treatment by Sept. 26 as a quarterly or monthly preventative treatment for migraine headaches. In December Aycardi said fremanezumab has the potential to become the “go-to treatment” for migraine headaches because the drug directly blocks the CGRP ligand and also reduces the need for additional acute pain medications for migraines.
Fremanezumab is also being investigated as a preventive treatment for several additional disorders including cluster headache and post traumatic headache disorder.
Teva is in the midst of a comprehensive restructuring plan that includes the elimination of 25 percent of the company’s global workforce, approximately 14,000 jobs, as well as the closure of a number of R&D facilities. The company has been looking to reduce its massive debt load of about $30 billion. By eliminating 14,000 jobs, it expects to save $3 billion by the end of 2019.