FDA Approves Aimovig (erenumab-aooe), A Novel Treatment Developed Specifically For Migraine Prevention
Migraine is a Severe Neurologic Disease That Profoundly Impacts Millions of Patients in the United StatesAimovig is the First and Only FDA-Approved Treatment to Block the Calcitonin Gene-Related Peptide Receptor (CGRP-R), Which Plays an Important Role in MigraineAimovig was Consistently Shown to Reduce Monthly Migraine Days, Including in More Difficult-to-Treat Populations, With Many Patients Achieving at Least a 50 Percent Reduction
THOUSAND OAKS, Calif., --?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."
The European Medicines Agency (EMA) Marketing Authorization Application (MAA) for Aimovig is under review. The companies expect approval in the EU in the coming months.
Amgen to Webcast Investor Call on Aimovig FDA Approval
Amgen?will host a webcast call for the investment community on?Friday, May 18, 2018, at?6 a.m. PT / 9 a.m. ET.?Anthony C. Hooper, executive vice president of Global Commercial Operations at?Amgen, and Paul Hudson, chief executive officer of Novartis Pharmaceuticals, will participate to discuss the recent FDA approval of Aimovig.
Live audio of the investor call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in?Amgen's?business given by management at certain investor and medical conferences, can be found on?Amgen's?website,?www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on?Amgen's?Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.
About Aimovig? (erenumab-aooe)
Aimovig is the only FDA-approved treatment specifically developed to prevent migraine by blocking the CGRP-R, which is associated with migraine. Aimovig has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention. More than 3,000 patients have participated in the Aimovig clinical program across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.
About LIBERTY
LIBERTY (NCT03096834) is a Phase 3b, multicenter, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in patients with episodic migraine (defined in the trial as four to 14 migraine days per month at baseline) who have failed up to four prior preventive treatments for migraine. In the study, 246 participants with episodic migraine who had two to four previous treatment failures were randomized to receive Aimovig 140 mg or placebo during the 12-week double-blind treatment phase. The primary endpoint was the percentage of patients with at least a 50 percent reduction of monthly migraine days from baseline over the last four weeks of the double-blind treatment phase of the study (weeks 9-12).1
U.S. Aimovig Indication
Aimovig is indicated for the preventive treatment of migraine in adults.
U.S. Aimovig Important Safety Information
- The most common adverse reactions in clinical studies (= 3% of Aimovig?-treated patients and more often than placebo) were injection site reactions and constipation.