NORTH CHICAGO, Ill., – August 5, 2020 – AbbVie today announced Serena Williams as the spokesperson for UBRELVY® to raise awareness of an effective acute treatment option for people living with migraine. Whether at work, taking care of kids, or preparing for a Grand Slam Championship tennis match like Serena, UBRELVY can provide relief of migraine attacks. Unlike older migraine medicines that primarily work by constricting blood vessels after a migraine attack has already begun, UBRELVY is the first pill of its kind for the acute treatment of migraine to directly block a protein called CGRP (calcitonin gene-related peptide), which is believed to play a critical role in migraine attacks. Available by prescription since January 2020, UBRELVY is approved for the acute treatment of migraine with or without aura in adults. It is not indicated for the preventive treatment of migraine.
Migraine afflicts more than 39 million Americans and is the third most common disease, second leading cause of disability worldwide, and first among individuals under 50 years old.2-5 This disease impacts three times more women than men, and 44% of those living with migraine remain undiagnosed.6,7 Serena has dealt with the debilitating symptoms of migraine all her adult life, all while juggling her professional tennis career, time with her family, and busy life overall.
“Migraine attacks are debilitating – and no one should have to endure them in their day-to-day life,” said Serena Williams. “I am excited to partner with UBRELVY because it relieves my migraine attacks quickly and effectively. I hope sharing my story will provide relief to others who suffer from migraine attacks too.”
In UBRELVY clinical trials, many people had pain relief within 2 hours and some even had pain relief within 1 hour. Also, in clinical trials, few people experienced side effects. The most common were nausea at 2-4% and tiredness at 2-3%.
This new, multichannel marketing campaign featuring Serena will highlight how UBRELVY works for people with different lifestyles by helping individuals treat their migraine attacks anytime, anywhere. In clinical trials, people took UBRELVY within four hours of a migraine attack. As spokesperson, Serena will be featured in a video, available on social media, talking with neurologist and paid AbbVie consultant, Dr. Jennifer McVige, about her experience with migraine and UBRELVY. Serena will also be included in print and digital advertising and other marketing initiatives that will be rolled out soon.
“Serena’s endless accomplishments on and off the court make her the right spokesperson and role model to raise awareness about this debilitating disease,” said Aimee Lenar, Vice President, U.S., Central Nervous System (CNS) at AbbVie. “As a respected athlete, entrepreneur and mother, Serena continues to push boundaries time and again. She is a shining example of how to successfully navigate life’s challenges while fighting migraine. We are pleased she has been able to find relief from her migraine pain with UBRELVY.”
If you are experiencing migraine symptoms and want to learn more about an effective treatment option that works for Serena, please visit www.UBRELVY.com for more information.
IMPORTANT SAFETY INFORMATION
Who should not take UBRELVY (ubrogepant)?
Do not take UBRELVY if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, itraconazole.
What should I tell my healthcare provider before taking UBRELVY?
Tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY with other medicines.
What are the most common side effects of UBRELVY?
The most common side effects are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY.
What is UBRELVY® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.
Please see full Prescribing Information.
About UBRELVY (ubrogepant)
UBRELVY (ubrogepant) is a novel, highly potent, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. Unlike older medications, UBRELVY is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments are known to do.
Migraine is a complex, chronic disease with episodic attacks that are often incapacitating and characterized by headache pain as well as neurologic and autonomic symptoms. It is highly prevalent, affecting more than one billion people worldwide, and is the highest cause of disability worldwide for people under 50 years of age. Due to the unpredictability and fluctuation of attack frequency and severity, migraine has substantial impact on many aspects of an individual’s life both during and between attacks. Daily activities, work, school, and personal relationships are negatively affected, leading to a significant burden on the person with migraine, their family, and friends, and often extending to employers and healthcare systems.
About AbbVie Leadership in Migraine
AbbVie, a leader in the migraine space, markets BOTOX® (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with Chronic Migraine and UBRELVY (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults. AbbVie is also advancing its migraine program with atogepant, an investigational small molecule CGRP receptor antagonist (gepant) being studied for the prevention of migraine. Atogepant is currently in Phase 3 development; the safety and efficacy has not been established.
BOTOX® is a prescription medicine that is injected to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.
It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine.
BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Do not receive BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.
Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.
Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; and drooping eyebrows.
For more information refer to the Medication Guide or talk with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, “Risk Factors,” of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
SOURCE AbbVie Inc.