Israel-based Teva Pharmaceuticals announced that it is halting the clinical development of fremanezumab (Ajovy) for cluster headaches. They based the decision on a pre-specified futility analysis of a Phase III clinical trial in episodic cluster headaches.
Israel-based Teva Pharmaceuticals announced that it is halting the clinical development of fremanezumab (Ajovy) for cluster headaches. They based the decision on a pre-specified futility analysis of a Phase III clinical trial in episodic cluster headaches. The analysis found that the primary endpoint of mean change from baseline in the number of cluster headache attacks in a weekly average weren’t likely to be met during the 4-week treatment period.
Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and prevents it from binding to the receptor. It is marketed for migraine headaches under the name Ajovy.
Based on the data, Teva is ending the ENFORCE Phase III clinical trial program, including a long-term safety study. It has also included a chronic cluster headache trial, which was halted in June 2018.
The company will continue to investigate fremanezumab for other indications. It is currently in a Phase II trial for post-traumatic headaches. That was also based on a pre-specified futility analysis.
There were no safety concerns for the drug.
Cluster headaches are severe headaches that generally occur for a long time period, a week to a year. The headaches are followed by a pain-free period. Cluster headaches are viewed as the most severe form of recurrent pain.
“We’d like to thank the patients and investigators for their immense contributions to this study,” stated Tushar Shah, senior vice president, Head of Global Specialty Clinical Development at Teva. “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.”
Calcitonin gene-related peptide (CGRP) is a popular target for treatments of migraines and chronic headaches. Amgen and Novartis’ Aimovig for migraine is a CGRP inhibitor approved by the U.S. Food and Drug Administration in May 2018. The approval was based on Phase III data showing Aimovig cut monthly migraine attacks in half.
In September 2018, the FDA approved Teva’s fremanzumab for migraine prevention. It is marketed under the brand name Ajovy. It was approved with both a quarterly (675 mg) and monthly (225 mg) dosing options.
At the time, Stephen Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University Hospital and lead investigator of the Phase III clinical program for Ajovy, stated, “Migraine is a disabling neurological disease that affects more than 36 million people in the United States. About 40 percent of people living with migraine may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”
At that time, it was also announced that the U.S. Wholesale Acquisition Cost (WAC) of Ajovy was $575 per monthly dose and $1,725 per quarterly dose. Teva has a program called Teva Shared Solutions to provide support services for patients and offices. Patients with commercial insurance plans could pay as little as $1 on Ajovy prescriptions.
Ajovy came on the market about four months after Aimovig. Both are CGRP blockers. The news today about the product failing in cluster headaches is undoubtedly a blow, since Teva has been making major cost-cutting efforts and facing intense competition for its multiple sclerosis drug Copaxone, as well as its battered generic drugs in the U.S.
2018 year-end sales were down about 16% in general for Teva, with full-year revenue of $18.85 billion. The drop was mostly due to decreased sales of Copaxone because of generic competition. In the short period between launch and the end of 2018, Ajovy brought in $3 million and is expected to bring in $150 million this year.
