FDA approves Novartis’ preventive migraine drug Aimovig
The Food and Drug Administration on Thursday approved Novartis’ Aimovig (erenumab-aooe), the first preventive migraine treatment in a new class of drugs. Aimovig, a once-monthly self-injected drug, works by blocking the activity of a molecule involved in migraines called calcitonin gene-related peptide, the FDA said.
"Aimovig provides patients with a novel option for reducing the number of days with migraine," said Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition."
Aimovig is injected using Amgen’s SureClick autoinjector device, which means it does not require a loading dose. Phase II and III studies saw Aimovig use leading to a reduction in monthly migraine days and use of acute migraine medication compared with the placebo, Novartis said.
"The FDA approval of Aimovig reflects the Novartis commitment to advancing neuroscience and marks an important moment in the fight against migraine," said Fabrice Chouraqui, U.S. president of Novartis Pharmaceuticals. “Migraine is a serious and misunderstood disease with significant gaps in the way it is both perceived and treated. In close partnership with Amgen, our goal in the US is to bring meaningful therapeutic options to patients, while also helping them to overcome the personal, professional and clinical barriers that have long been associated with this stigmatized disease.”
Novartis said the drug’s list price is $6,900 annually, or $575 per monthly SureClick autoinjector. The company said that its Aimovig Copay Program could bring a patient’s out-of-pocket cost to as little as $5 per month for eligible patients with commercial insurance.
Novartis expects the drug to be available within a week.
"Aimovig provides patients with a novel option for reducing the number of days with migraine," said Eric Bastings, deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We need new treatments for this painful and often debilitating condition."
Aimovig is injected using Amgen’s SureClick autoinjector device, which means it does not require a loading dose. Phase II and III studies saw Aimovig use leading to a reduction in monthly migraine days and use of acute migraine medication compared with the placebo, Novartis said.
"The FDA approval of Aimovig reflects the Novartis commitment to advancing neuroscience and marks an important moment in the fight against migraine," said Fabrice Chouraqui, U.S. president of Novartis Pharmaceuticals. “Migraine is a serious and misunderstood disease with significant gaps in the way it is both perceived and treated. In close partnership with Amgen, our goal in the US is to bring meaningful therapeutic options to patients, while also helping them to overcome the personal, professional and clinical barriers that have long been associated with this stigmatized disease.”
Novartis said the drug’s list price is $6,900 annually, or $575 per monthly SureClick autoinjector. The company said that its Aimovig Copay Program could bring a patient’s out-of-pocket cost to as little as $5 per month for eligible patients with commercial insurance.
Novartis expects the drug to be available within a week.