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Late Thursday, Amgen (NASDAQ: AMGN) announced that the FDA approved Aimovig for the preventative treatment of migraine in adults. Aimovig is a novel therapeutic approach that was developed as the first and only FDA-approved treatment for the prevention of migraine by blocking the receptor for cephalone gene-associated peptides (CGRP-R), which is believed to play a critical role plays in migraine. Aimovig 70 mg is administered once a month via the Amgen device, the SureClick® autoinjector, and does not require a loading dose. Some patients may benefit from a dose of 1
To read the Multimedia News Release, go to: https://www.multivu.com/players/English/8004556-amgen-aimovig-fda -Approval / .
"Migraine is a serious neurological disorder that has a dramatic impact on the lives of patients, migraine sufferers suffer from agonizing headaches, often accompanied by other symptoms such as nausea and vomiting, and many live in constant fear of the next attack," said Sean E. Harper, MD, Executive Vice President of Research and Development, Amgen. "Aimovig's FDA approval represents a long-awaited and important therapeutic development for patients and their physicians seeking additional treatment options for the prevention of migraine."
In Phase 2 and 3 trials in chronic and episodic migraine, Aimovig resulted in a significant reduction in monthly migraine days and the use of acute migraine medications compared to placebo. These effects on monthly migraine days have been shown in an ongoing open-label extension study of episodic migraine (four to 14 headache days per month) for up to 15 months.
A special Phase 3b study (LIBERTY) in hard-to-treat populations – those with episodic migraine that failed two to four previous treatments – showed that patients taking Aimovig were almost three times more likely to have their Migraine days compared to placebo by half or more. [Aimovig'sefficacytolerabilityandsafetyhavebeenstudiedinmorethan3000patientsincludingLIBERTYandarollingopen-labelextensionofuptofiveyearsInclinicaltrialswithAimovigthemostcommonsideeffectswereinjectionsitereactionsandconstipation
"A treatment focused specifically on the complex nature of migraine is an important and welcome step in headache medicine, and Aimovig offers self-administration of proven efficacy to a broad range of patients, including those who have previously tried other preventive therapies without success "said Stewart J. Tepper, MD, a professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, Aimovig's patients were able to start and stay in clinical trials at a two percent drop-off rate due to adverse events and experienced persistent migraine prophylaxis."
"For years, the migraine community has been advocating new treatment options specifically designed to treat migraines, a debilitating and often stigmatized condition," said Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients (CHAMP), which represents 12 national groups of patients with headache and migraine. "Today, we celebrate the untiring work of researchers to better understand the biology of migraine and its ability to help millions of Americans who seek fewer migraine days." On behalf of the community, we also want to thank the thousands of clinical trial patients, their unwavering commitment facilitated this progress. "
Amgen and Novartis are committed to supporting the migraine community and helping eligible patients with affordable access to Aimovig. The Aimovig Ally ™ product support program was developed to help patients find insurance coverage and to identify potential access resources for uninsured or uninsured insureds.
Aimovig's US list price is $ 575 for a once-monthly 70 or 140 mg pre-filled SureClick® auto-injector (singly) or $ 6,900 per year. The price of Aimovig reflects the value that it brings to patients and society, including the financial impact on those affected, carers and employers. Critical aspects such as affordability of patients and fair and timely access are taken into account.
The cost of the bag varies depending on the insurance status. The Aimovig Copay program may be able to help reduce a patient's expenses of up to $ 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 a week.
"In addition to As a new therapeutic option for patients in the US, Amgen has also committed to re-shaping the public's perception of this stigmatized disease," said Anthony C. Hooper, executive vice president of global commercial operations at Amgen. "We are committed to changing the misconceptions, stereotypes and even the judgment of people with migraines on a daily basis, and through education programs and initiatives we hope to foster more meaningful connectivity and better dialogue between patients, physicians, employers and payers."
The application for authorization of the European Medicines Agency (EMA) for Aimovig is under consideration. The companies expect approval in the EU in the coming months.
Amgen to Webcast Investor Call on FDA Approval by Aimovig On Friday, May 18, 2018, Amgen will be launching a webcast call for the investment community on May 6, am PT / 9 pm ET. Anthony C. Hooper, Amgen's Executive Vice President of Global Commercial Operations, and Paul Hudson, Novartis Pharmaceuticals' Chief Executive Officer, will attend the meeting to discuss Aimovig's recent FDA approval.
live audio of the investor call will be simultaneously broadcast on the Internet and will be accessible to members of news media, investors and the public.
The webcast, as well as other selected presentations regarding developments in Amgen's business, which management has given at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com Investors , For presentation times, availability of webcasts, and links to the webcast, visit the Amgen Investor Relations Events Calendar. The webcast will be archived and will be available for playback for at least 90 days after the event.