Amgen: The FDA Approves Aimovig™. The First Specific Migraine Drug.

The U.S. Food and Drug Administration (FDA) approved Amgen’s (AMGN) new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in the occurrence of migraine.

The drug will be marketed by Amgen and Novartis (NVS). 

Aimovig 70 mg is self-administered once monthly using SureClick®autoinjector, device without requiring a loading dose. Some patients may benefit from a dosage of 140 mg once monthly.

Migraine is a severe neurological disease. It is not a simple headache. Migraine patients experience excruciating pain, nausea, and vomiting. Severe migraines disable people who cannot function properly during the attacks, which sometimes exhaust the patients for days before the pain leaves their heads to then come back to repeat the same.

The FDA approval of Aimovig is a game changer in the management of migraine.   

In Phase 2 and 3 studies in chronic and episodic migraine, Aimovig significantly reduced monthly migraine days and the use of acute migraine medications compared to placebo. These effects on monthly migraine days have been durable for up to 15 months in an ongoing open-label extension study in episodic migraine (four to 14 headache days per month).

In a Phase 3b study (LIBERTY) dedicated for difficult-to-treat populations (people with episodic migraine who have failed two to four prior treatments), Aimovig had nearly three-fold higher odds of cutting migraine days 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.

Stewart J. Tepper, M.D., professor of neurology at the Geisel School of Medicine at Dartmouth Medical School commented on the drug’s approval stating, “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. 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.”

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.

Amgen is hosting a webcast call for the investment community today starting at 6 a.m. PT / 9 a.m. ET. Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen, and Paul Hudson, a 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.

AIMOVIG

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. Aimovig is indicated for the preventive treatment of migraine in adults.

The most common adverse reactions in clinical studies (≥ 3% of Aimovig™-treated patients and more often than placebo) were injection site reactions and constipation.

Prohost Observations

A fact that people with migraine recognize well and confirm is that half their life is lost to their migraine. Migraine victims endure excruciating debilitating pain and physical impairment, in addition to living in constant dread of the next attack. Migraine is ranked among the top 10 causes of years lived with disability worldwide. It is associated with personal and societal burdens of pain, disability, under-recognition and yet to have a specific treatment.   

 Kevin Lenaburg, executive director of the Coalition For Headache And Migraine Patients (CHAMP), which represents 12 national headache and migraine patient advocacy groups said, “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. 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.”

Pricing: Asking for the drug’s price, a 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.

Amgen is expected to grow its revenues by $1 billion a year.

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.

This is great news for migraine patients and for Amgen and its Scientists. We appreciate the firm and scientists realization of a dream that seemed unrealizable, which is bringing back full life to migraine sufferers who had lost half of it to migraine.  

Prohost Letter #421 will be posted next week.

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