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Teva wins FDA nod for migraine prevention drug

September 17, 2018 By Sarah Faulkner

Teva Pharmaceutical's Ajovy migraine drugTeva (NYSE:TEVA) last week won FDA approval for its humanized monoclonal antibody, Ajovy, designed to prevent migraines.

The treatment, which blocks the receptor for a protein that is linked to migraine pain, is available in quarterly and monthly-injection options. Amgen‘s (NSDQ:AMGN) competitive once-monthly product won FDA approval earlier this year.

Teva studied Ajovy in two Phase III trials involving patients with disabling migraines and found that while the drug couldn’t completely eliminate migraines, patients experienced a reduction in monthly migraine days.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” lead investigator Dr. Stephen Silberstein said in prepared remarks. “About 40% 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.”

“This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system,” president & CEO Kåre Schultz added. “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.”

Teva reported that it plans to sell the drug at $575 per monthly dose and $1,725 per quarterly dose – in line with Amgen’s pricing. Teva also noted that it expects Ajovy to be available via pharmacies in roughly two weeks.

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Filed Under: Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Amgen, Teva Pharmaceuticals

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