With a priority review voucher in hand, Teva Pharmaceuticals is expecting the U.S. Food and Drug Administration to rule on its new migraine treatment fremanezumab by June.

On Dec. 15, the FDA accepted Teva’s Biologics License Application for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine headaches. Anti-CGRPS are a popular choice to treat migraine headaches. In addition to Teva, companies like Allergan and Amgen are rushing to have their therapies be approved to treat patients. While anti-CGRPs may seem like the drug of the hour in migraine therapy, Ernesto Aycardi, the head of migraine and headache R&D at Teva, said the importance of the therapeutic target cannot be understated when it comes to treating the debilitating headaches.

"The importance of CGRP in migraine today is not to be missed. This is the first time that molecules have been developed specifically for migraine headaches," Aycardi told BioSpace in an exclusive interview.

The BLA filed by Teva includes Phase III data from the HALO clinical trial program that included more than 2,000 patients with episodic migraine and chronic migraine pain. Patients who received the treatment were given a monthly injection or an injection every three months to treat the migraine. Data showed fremanezumab achieved statistically significant results across all trial endpoints. The chronic migraine results were recently published in The New England Journal of Medicine.

In the past, there have been a number of treatments that provided relief to migraine sufferers, but many of them were off-label, such as Allergan’s cosmetic agent Botox, Aycardi said. But with pending approval of fremanezumab, Aycardi believes Teva has a product on hand that has the potential to become the "go-to treatment" for migraine headaches. He said the Teva designed drug goes to directly block the CGRP ligand, which is a well-identified migraine target. While it has a specific target, Aycardi said fremanezumab does more than just reduce the number of headache days in migraine patients. Not only does the drug reduce the number of headache days, it also reduces the disability in patients as well by reducing their need for additional acute pain medications for migraines, Aycardi said. By doing so, patients who take fremanezumab do not have to rely on acute pain medication. The trigeminal nerve, which is the source of migraine pain, is rich in CGRP. That’s what makes fremanezumab such an effective treatment for migraines, Aycardi said.

"We are reducing the need for acute medications and reducing the number of migraine-specific medications patients need," Aycardi said. "Just to complete the package we have data supporting dosing monthly or once every three months. This way patients can customize the treatment."

In addition to strong efficacy, fremanezumab has also shown a solid safety profile, which will make it more attractive to patients and prescribers, Aycardi said.

In clinical trials, fremanezumab has shown efficacy in treating both chronic migraine headaches and episodic migraine headaches. Patients with chronic migraines suffer 15 or more headache days per month. Patients with episodic migraines suffer 14 or less headache days per month.

"People who have multiple migraine headaches can become withdrawn from daily society. The impact fremanezumab will be amazing for people. It will really improve their lives," Aycardi said.

Fremanezumab is currently being investigated for the prevention of chronic and episodic cluster headache as part of the Phase III Enforce clinical research program, which has been granted fast track designation by the FDA.

In addition to benefiting migraine patients, Aycardi said fremanezumab is also showing efficacy in two other kinds of headaches – cluster headaches and post-traumatic headaches. Cluster headaches are considered to be the most severe form of recurrent pain. Teva is studying fremanezumab in a Phase III trial. Post-traumatic headaches occur following a significant injury that can result in the loss of consciousness. Aycardi said the pain associated with this type of headache can impair quality of life and Teva believes fremanezumab can be a significant benefit for them. Studies for post-traumatic headaches are currently in Phase II.

While headaches are common links between these issues, those are only symptoms, Aycardi said. The pain originates in different parts of the head, but fremanezumab is demonstrating that it can treat each of these issues, he added.

Although Teva is in the middle of a strategic reorganization that will result in the loss of thousands of jobs and the possible divestment of some assets, Aycardi said the company remains committed to the migraine space.

"That’s a firm commitment from the company," Aycardi said. "We are looking to bring new solutions to migraines."