FDA Approves QULIPTA , the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine

ABBVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved QULIPTA™ (atogepant) for the preventive treatment of episodic migraine in adults. 1 QULIPTA is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. 2

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"Millions of people living with migraine often lose days of productivity each month because attacks can be debilitating. QULIPTA can help by reducing monthly migraine days with a once-daily, oral dose that works quickly and continuously," said Michael Severino , M.D., vice chairman and president, AbbVie. "We are proud that AbbVie is now the only pharmaceutical company to offer three products across the full spectrum of migraine treatment, which include preventive therapies for chronic and episodic migraine and an acute treatment for migraine attacks."

The approval is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of QULIPTA in nearly 2,000 patients who experienced 4 to 14 migraine days per month, including the pivotal Phase 3 ADVANCE study — which was published in The New England Journal of Medicine — the pivotal Phase 2b /3 study, and the Phase 3 long-term safety study. ^1,2

"When I have a migraine attack, my 5-year-old daughter doesn't understand why I can't take her to a birthday party or to the park. It's heartbreaking when I have to tell her I need to be away from her because my eyes feel like they're going to explode out of my head," said Kelsi Owens , an ADVANCE trial participant who has lived with migraine for nearly three decades. "During the trial while taking QULIPTA, I had many fewer migraine days. For the first time ever, I don't have difficulty doing my daily activities and I don't have to worry as much that a migraine attack will cause me to miss important events with family and friends."

Migraine is a complex disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. ⁴ It is highly prevalent, affecting more than 1 billion people worldwide, including 39 million people in the U.S. alone, ⁵ and is the highest cause of disability worldwide for people under 50 years of age. ^6,7

"This approval reflects a broader shift in the treatment and management paradigm for the migraine community. QULIPTA provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients," said Peter J. Goadsby , M.D., Ph.D., D.Sc., neurologist and professor at University of California, Los Angeles , and King's College, London , who earned the prestigious Brain Prize in 2021 for his revolutionary research about CGRP's role in migraine attacks and co-authored the ADVANCE study.

"I'm particularly encouraged by the convenience of the oral daily use of QULIPTA, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates. This is a milestone in preventive migraine treatment that I hope will help many patients for years to come," Goadsby said.

Highlights from the clinical program supporting the approval and additional data analysis include:

• In the pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, the primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period. All QULIPTA dose groups met the primary endpoint and demonstrated statistically significant reductions in mean monthly migraine days compared to placebo. Patients treated with 60 mg of QULIPTA across 12 weeks experienced a 4.2-day reduction from baseline of 7.8. ¹
• A key secondary endpoint in the ADVANCE trial measured the proportion of patients that achieved a ≥50% reduction in monthly migraine days across the 12-week treatment period. The trial demonstrated that 56%/59%/61% of patients in the 10 mg/30 mg/60 mg QULIPTA arms, respectively, achieved a 50-100% reduction, compared to 29% of patients in the placebo arm (all dose groups vs. placebo, p<.001> 1
• All doses were well tolerated in the ADVANCE trial and pivotal Phase 2b /3 clinical trial evaluating the efficacy, safety and tolerability of orally administered QULIPTA. Adverse reactions in both studies (incidence at least 2% and greater than placebo) included nausea (5-9% across all doses versus 3% for placebo), constipation (6% across all doses versus 1% for placebo), fatigue/somnolence (4-6% across all doses versus 3% for placebo) and decreased appetite (1-2% across all doses versus 1
• The pivotal Phase 2b /3 trial demonstrated that all active treatment arms met the primary efficacy endpoint of change from baseline in mean monthly migraine days with significantly greater reductions in mean monthly migraine days across the 12-week treatment period for all three QULIPTA treatment groups compared with placebo. All three QULIPTA treatment groups also met the secondary efficacy endpoint of change from baseline in mean monthly headache days. ¹

More information about the clinical program can be found on www.clinicaltrials.gov (NCT03777059, NCT02848326 and NCT03700320).

About QULIPTA™

QULIPTA™ (atogepant) is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths – 10 mg, 30 mg and 60 mg.

QULIPTA will be available in early October 2021 . AbbVie believes people living with migraine should have access to all new medications for this debilitating disease. Visit www.QULIPTA.com for more information.

QULIPTA™ Indication

QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of episodic migraine in adults.

IMPORTANT SAFETY INFORMATION

ADVERSE REACTIONS

The most common adverse reactions (≥4% and greater than placebo) are nausea, constipation, and fatigue.

DOSAGE AND ADMINISTRATION:

DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: 10 mg once daily.
Strong and Moderate CYP3A4 Inducers: 30 mg or 60 mg once daily.
OATP Inhibitors: 10 mg or 30 mg once daily.

USE IN SPECIFIC PATIENT POPULATIONS

Severe Renal Impairment or End-Stage Renal Disease: 10 mg once daily.
Avoid use in patients with severe hepatic impairment.

Full prescribing information can be found here .

More information about QULIPTA is available for healthcare professionals at www.QULIPTAHCP.com .

BOTOX® Indication

BOTOX® is a prescription medicine that is injected into muscles and used:

• 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 and 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®:

• Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
• Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

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 its 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, any other 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 have 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 injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX® include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; 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.

Please see BOTOX® full Prescribing Information including Boxed Warning and Medication Guide .

UBRELVY® Indication

UBRELVY® (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVY® is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION

Contraindication: Concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin).

Adverse Reactions: The most common adverse reactions were nausea (4%) and somnolence (3%).

Please see UBRELVY® full Prescribing Information .

About AbbVie in Migraine

Impacting one billion people worldwide, migraine is a neurological disease with recurring attacks that cause pain and other disabling symptoms. ⁵ However, migraine can be treatable. At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.

Our portfolio of therapies, which serves the varying needs of people living with migraine, includes BOTOX ^® (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with chronic migraine; UBRELVY ^® (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), indicated for the acute treatment of migraine with or without aura in adults; and QULIPTA™ (atogepant), the first and only oral CGRP antagonist specifically developed for the preventive treatment of episodic migraine in adults.

About AbbVie

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 , LinkedIn or Instagram .

Forward-Looking Statements

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   2020   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.

References:

1. QULIPTA™ (atogepant) [Package Insert]. North Chicago, Ill. : AbbVie Inc.

2. AbbVie. (2021, March 30 ). U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine. Available at: https://news.abbvie.com/news/press-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-preventive-treatment-migraine.htm

3. ClinicalTrials.gov. Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine. Available at: https://clinicaltrials.gov/ct2/show/results/NCT03700320

4. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.

5. Migraine Research Foundation. Migraine Facts. Available at: https://migraineresearchfoundation.org/about-migraine/migraine-facts/#:~:text=Migraine%20is%20an%20extraordinarily%20prevalent,U.S.%20and%201%20billion%20worldwide .

6. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1211-1259.

7. Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., & Katsarava, Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17.

SOURCE AbbVie

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SOURCE AbbVie