Dec 07, 2020
  • - The Know Migraine Mission initiative seeks to challenge misconceptions and start new conversations about migraine
  • - Karamo Brown to connect directly with people affected by migraine to share experiences and advice during this challenging time
  • - COVID-19 has had a significant impact on people who live with migraine,1 so it's more important than ever to offer compassion and understanding around the disease

EAST HANOVER, N.J., Dec. 7, 2020 -- Novartis today announced a partnership with Karamo Brown, Emmy-nominated host from Netflix's hit show "Queer Eye," to support and empower people living with migraine. Karamo, who is known for helping people open up about themselves, is discussing his own struggles with migraine for the first time to help spread knowledge and acceptance. The Know Migraine Mission is a national effort by the companies behind Aimovig® (erenumab-aooe) to challenge public misconceptions, start new conversations and make the world a more migraine-friendly place. As part of the initiative, Karamo, who is not an Aimovig® patient but has dealt with migraine for years, will share his thoughts with people personally affected by migraine along with their friends, families and coworkers to help increase understanding of the disease.

"We've all been feeling the stress of this year, and it's compounded if you live with migraine like me. However, some people don't realize how challenging this disease can be, which is why I'm excited to lend my voice to the Know Migraine Mission," said Karamo. "For people with migraine, talking about it can help make a real difference in their lives. Those conversations are important, even though they might look different today – so, whether it's a social-distanced lunch date with a friend or a video call with a doctor, it's important to take control where possible."

Migraine is a complex neurological disease that impacts millions of people in the U.S.2-5 Despite its prevalence and severity, migraine is often misunderstood and dismissed as being "just a headache."6 Research shows people may often feel stigmatized for missing time with friends, family and co-workers because of their migraine.2,6

Karamo has struggled with migraine since he was in high school. The disease has impacted many parts of his life, including his ability to spend time with his two sons and other family and friends. As part of this partnership, Karamo is answering questions and sharing his thoughts with others who are living with this disease. On KnowMigraineMission.com and social media, including the Aimovig Facebook and Instagram pages, Karamo will address how others can start new conversations to help reduce the stigma around migraine.6

Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the first Food and Drug Administration (FDA)-approved treatment indicated to prevent migraine in adults by targeting the calcitonin gene-related peptide (CGRP) receptor.7 Clinical study results have established the efficacy and safety profile of Aimovig across a spectrum of people living with both episodic and chronic migraine.8,9

"As the most prescribed preventive therapy in its class, Aimovig is proven to help prevent monthly migraine days before they start – in some cases, it can cut that number of monthly migraine days in half or more," said Victor Bultó, President, Novartis Pharmaceuticals Corporation. "However we want to support the migraine community beyond medicine, which is why we're thrilled to partner with Karamo Brown to encourage new and honest conversations about this disease. Our sincere hope is that the Know Migraine Mission helps provide the migraine community with the awareness and support they need and deserve."

To learn more about Karamo's story and for additional information and resources, visit KnowMigraineMission.com and follow Aimovig on Facebook and Instagram.

About the Know Migraine Mission
The Know Migraine Mission is a national effort by Novartis and Amgen to challenge public misconceptions, start new conversations and make the world a more migraine-friendly place. The way migraine can be treated has changed,7 but the way people with migraine are treated still has a long way to go. Novartis and Amgen believe the more vocal and visible people with migraine are, the more others will recognize the debilitating effects of this disease.5

About Aimovig® (erenumab-aooe) 
Aimovig, co-marketed in the U.S. by Amgen and Novartis, is the first FDA-approved migraine preventive treatment that targets the calcitonin gene-related peptide (CGRP) receptor, which is associated with migraine.7,11 Aimovig has been studied in several large, global, randomized, double-blind, placebo-controlled studies to assess its efficacy and safety in migraine prevention.9,10 Aimovig is self-administered once monthly via the easy-to-use SureClick® autoinjector, without a required loading dose.7,12 More than 3,000 patients participated in registrational trials of Aimovig across four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extensions.8,9,10,13,14

Aimovig is also being evaluated through CATALYST, a comprehensive evidence generation program initiated by Amgen and Novartis that includes over 7,500 patients across ongoing clinical trials and a robust assessment of real-world evidence. Spanning over 39 countries globally, CATALYST clinical trials will explore the role of Aimovig in comparative studies, assessing impact on novel migraine outcomes, understanding predictive biomarkers and investigating Aimovig's use in additional study populations. To date, more than 480,000 patients worldwide have been prescribed Aimovig for the preventive treatment of migraine in adults.15 

AIMOVIG INDICATION
Aimovig® (erenumab-aooe) is indicated for the preventive treatment of migraine in adults.

IMPORTANT SAFETY INFORMATION
Contraindication: Aimovig® is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with Aimovig® in post marketing experience. Most reactions were not serious and occurred within hours of administration, although some occurred more than one week after administration. If a serious or severe reaction occurs, discontinue Aimovig® and initiate appropriate therapy. 

Constipation with Serious Complications: Constipation with serious complications has been reported following the use of Aimovig® in the postmarketing setting. There were cases that required hospitalization, including cases where surgery was necessary. The onset of constipation was reported after the first dose in a majority of these cases, but patients also reported later on in treatment. Aimovig® was discontinued in most reported cases. Constipation was one of the most common (up to 3%) adverse reactions reported in clinical studies.

Monitor patients treated with Aimovig® for severe constipation and manage as clinically appropriate. Concurrent use of medications associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications.

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of Aimovig® in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. Aimovig® was discontinued in many of the reported cases.

Monitor patients treated with Aimovig® for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of Aimovig® is warranted if evaluation fails to establish an alternative etiology.

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

Please see Aimovig® full Prescribing Information.

About Migraine
People with frequent migraine attacks may lose more than half their life to migraine.16,17 One attack could last up to three days.16 They endure debilitating pain, physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.5,6 The 2017 Global Burden of Disease Study ranks migraine among the top 10 causes of years lived with disability worldwide.18 Migraine is associated with personal and societal burdens of pain, disability and financial cost, and it remains under-recognized and under-treated.2,19

 

About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to develop and commercialize pioneering treatments in the field of migraine. The collaboration focuses on investigational Amgen drugs in the migraine field, including Aimovig (approved by the FDA in May 2018 for the preventive treatment of migraine in adults).7 In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine programs, Amgen retains exclusive commercialization rights in the U.S. (other than for Aimovig as described above) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world. At the center of the Amgen and Novartis neuroscience collaboration is the shared mission to fight migraine and the stereotypes and misperceptions surrounding this debilitating disease.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of Novartis AG – is reimagining medicine to improve and extend people's lives. As a leading global medicines company, Novartis uses innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs about 15,000 people in the United States. For more information, please visit https://www.novartis.us.

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References

  1. Al-Hashel and Ismail. Impact of coronavirus disease 2019 (COVID-19) pandemic on patients with migraine: a web-based survey study. The Journal of Headache and Pain. (2020) 21:115.
  2. Lipton R, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5)343-349.
  3. US Census Bureau. Age and Sex 2014-2018 American Community Survey 5-Year Estimate. https://data.census.gov/cedsci/table?q=united% 20states&tid=ACSDP5Y2018.DP05&hidePreview=true. Accessed October 21, 2020.
  4. Buse DC, Manack AN, Fanning KM, et al. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012;52(10):1456-1470.
  5. Russo AF. Calcitonin gene-related peptide (CGRP): A new target for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
  6. Rutberg S, Ohrling K. Migraine – more than a headache: Women's experiences of living with migraine. Disabil Rehabil. 2012;34(4):329-336.
  7. Aimovig® (erenumab-aooe) prescribing information, Amgen, April 2020.
  8. Ashina M, Goadsby P, Reuter U, et al. Sustained efficacy and long-term safety of erenumab inpatients with episodic migraine: results of a 5-year, open-label extension study. Presented at The 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
  9. Tepper S, Ashina M, Reuter U, et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017;16(6):425-434. doi:10.1016/S1474-4422(17)30083-2.
  10. Olesen J, Diener HS, Husstedt I, et al. Calcitonin gene-related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine. N Engl J Med. 2004;350(11):1104-1110.
  11. Sun H, Dodick DW, Silberstein S, et al. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):382-390. doi:10.1016/S1474-4422(16)00019-3.
  12. Data on File. Amgen. May 2019.
  13. Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Sustained Efficacy and Safety of Erenumab in Episodic Migraine Patients Failing 2–4 Prior Preventive Treatments: 2-year Interim Results of the LIBERTY Open-Label Extension Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
  14. Wang S-J, Roxas Jr, A, Saravia B, et al. Efficacy and Safety of Erenumab in Patients with Episodic Migraine from the EMPOWER Study. Presented at the 18th Migraine Trust Virtual Symposium; October 3-9, 2020; London, U.K.
  15. Data on File. Novartis. October 2020.
  16. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
  17. Lipton R, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001;41(7):1-211.
  18. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392:1789-1858.
  19. Diamond S, Bigal ME, Silberstein S, et al. Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention study. Headache. 2007;47(3):355-363.

 

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