Amgen Inc. issued the following announcement on May 17.
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovig™ (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) – which is believed to play a critical role in migraine. Aimovig 70 mg is self-administered once monthly via Amgen's device, the SureClick® autoinjector, and does not require a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.
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"Migraine is a serious neurological disease that has dramatic effects on patients' lives. Migraine patients experience excruciating headache pain, often accompanied by other symptoms such as nausea and vomiting, and many live in constant dread of the next attack," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine."
In Phase 2 and 3 studies in chronic and episodic migraine, Aimovig resulted in significant reductions in monthly migraine days and use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown to be sustained for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).
A dedicated Phase 3b study (LIBERTY) in difficult-to-treat populations – those with episodic migraine who have failed two to four prior treatments – showed that patients taking Aimovig had nearly three-fold higher odds of having their migraine days cut by half or more compared to placebo.
The efficacy, tolerability and safety of Aimovig has been assessed in more than 3,000 patients, including LIBERTY and an ongoing open-label extension of up to five years in duration. In clinical studies of Aimovig, the most common adverse reactions were injection site reactions and constipation.
"Having a treatment designed to specifically address the complex nature of migraine is an important and welcome step forward in headache medicine. Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention."
"For years, the migraine community has been advocating for new treatment options that are specifically designed to treat migraine, a debilitating and often stigmatized disease," said Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP), which represents 12 national headache and migraine patient advocacy groups. "Today we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days. On behalf of the community, we would also like to thank the thousands of clinical trial patients whose unwavering commitment made this progress possible."
Amgen and Novartis are committed to supporting the migraine community and to helping appropriate patients with affordable access to Aimovig. The Aimovig Ally™ product support program has been created to help patients navigate insurance coverage and identify potential access resources for those who are uninsured or underinsured.
The U.S. list price of Aimovig is $575 for once monthly 70 or 140 mg single-use prefilled SureClick® autoinjector(s), or $6,900 annually. The price of Aimovig reflects the value it brings to patients and society, including the financial impact on sufferers, caregivers and employers, while also factoring in critical issues such as patient affordability, and fair and timely access.
While out-of-pocket costs will vary depending on insurance status, the Aimovig Copay Program may be able to help reduce a patient's out-of-pocket costs to as little as $5 per month for eligible patients with commercial insurance. For more information about Aimovig Ally™ and the Aimovig Copay Program, please visit www.aimovig.com.
Aimovig is expected to be available to patients within one week.
"In addition to bringing a new therapeutic option to patients in the U.S., Amgen also has a commitment to reshape the public's perception of this stigmatized disease," said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. "We have pledged a mission to help change misconceptions, stereotyping and even judgment that people with migraine face on a daily basis. Through educational programs and initiatives, we hope to promote more meaningful connectivity and dialogue among patients, physicians, employers and payers."
Original source can be found here.