FDA Action Alert: Migraine Treatment Approved by the FDA, Ready to Roll in 2 Weeks


The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries' Ajovy (fremanezumab) to prevent migraine on Friday, September 16.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, director, Jefferson Headache Center at Thomas Jefferson University Hospital and lead investigator of the Phase III clinical trial program for the drug, in a statement. “About 40 percent of people living with migraines 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.”

The drug is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand.

Despite the approval, Teva is running behind in this area. In May, the FDA approved Amgen and Novartis Aimovig (erenumab-aooe) for the prevention of migraines in adults. It was the first-and-only FDA-approved treatment designed to prevent migraines by blocking the calcitonin gene-related peptide receptor (CGRP-R). Aimovig 70 mg is self-administered once a monthly by way of Amgen’s SureClick autoinjector.

Ajovy may, however, have an advantage. It’s also injectable, but it only requires injections once every three months. However, in June, the company halted a Phase III clinical trial of the drug for prevention of chronic cluster headaches. They indicated at the time that it wasn’t likely to hit the primary goal of reducing the average number of cluster headaches in the 12-week treatment period. However, it proved to be effective in preventing migraine.

Eli Lilly is also developing a migraine drug in the same class, with an FDA action date of September 27.

Teva indicates they are ready to go with the drug and expect it to hit the market within the next two weeks. The U.S. Wholesale Acquisition Cost (WAC) for the drug is $575 per monthly dose and $1,725 for a quarterly dose. It will be available through retail and specialty pharmacies. Teva has also stated that commercially insured patients may pay as little as $0 until the offer expires. For patients looking for financial support, the company offers Teva Shared Solutions, with more details available at AJOVY.com.

Brendan O’Grady, head of Teva’s North America commercial operations, told Reuters, “We felt that $575 was an appropriate price.” It’s also the price Amgen and Novartis are charging for Aimovig.

A consensus of analyst projections compiled by Bloomberg estimates sales of around $500 million by 2022. Bloomberg writes, “Ajovy’s launch could help Teva, the world’s largest generic drugmaker, eventually replacing declining sales of Copaxone, its aging star product. Investors have tracked the new drug’s trajectory as one of the few channels of growth for the debt-laden pharma giant. Chief Executive Officer Kare Schultz embarked on a massive cost-cutting plan last year and placed debt repayment as his top priority, in effect shelving designs to increase sales in the coming two years.”

Part of Schultz’s cost-cutting measures have included laying off more than a quarter of Teva’s workforce and closing or selling 10 of its factories. In August, the company indicated its net debt had dropped from $35 billion to $28.4 billion.

In a statement, Schultz said, “This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system. The approval of Ajovy helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders — patients, employees and shareholders.”

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