Allergan Receives U.S. FDA Approval for UBRELVYâ„¢ for the Acute Treatment of Migraine with or without Aura in Adults
Allergan Receives U.S. FDA Approval for UBRELVYâ„¢ for the Acute Treatment of Migraine with or without Aura in Adults -- UBRELVYâ„¢ is the first and only oral CGRP receptor antagonist (gepant) FDA-approved for the acute treatment of migraine -- |
[23-December-2019] |
DUBLIN, Dec. 23, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for UBRELVYâ„¢ (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVYâ„¢ is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. Migraine is a neurological disease characterized by intermittent migraine attacks with symptoms that are often incapacitating. Migraine afflicts 31 million Americans and is the third most common disease and second leading cause of disability worldwide. Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8663051-allergan-ubrelvy-acute-treatment-migraine-fda-approval/ "The FDA's approval of UBRELVYâ„¢, a new oral option that is effective in the acute treatment of migraine attacks, is a much-welcomed development for me and for many who care for patients. I can offer my migraine patients a new treatment option that may work for them," said Dr. Peter Goadsby, Neurologist and Professor at King's College, London, and University of California, San Francisco, and a paid consultant for Allergan. "Perhaps even better, I am able to offer a new sense of hope for my patients who struggle for relief from this highly disabling problem." In clinical trials supporting the FDA's approval, UBRELVYâ„¢ provided quick pain relief for the majority of migraine patients. UBRELVYâ„¢ also met co-primary endpoints of freedom from pain and freedom from the most bothersome symptom (nausea, hypersensitivity to light, or hypersensitivity to sound), a recent, more stringent standard of efficacy the FDA set in 2018. UBRELVYâ„¢ provided lasting relief up to 24 hours as well. UBRELVYâ„¢ works in a new way by blocking CGRP, a protein that is released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments are known to do. UBRELVYâ„¢ is non-narcotic, not scheduled, and does not have addiction potential. It has been approved with two dose strengths, 50 mg and 100 mg, and is specially designed so healthcare providers can provide a personalized treatment approach for appropriate patients. "As someone living with migraine for 14 years, my life seems to be on pause when I experience a migraine attack," said Kristin Molacek, UBRELVYâ„¢ clinical trial patient. "During the clinical trial, my experience with UBRELVYâ„¢ was positive. It relieved the migraine symptoms that bothered me the most without serious side effects. We have needed this type of on-demand oral relief for a very long time, and I look forward to having the ability to better manage my migraine attacks." "We are extremely pleased that UBRELVYâ„¢ is now approved by the FDA. As the first oral gepant, UBRELVYâ„¢ offers a new and different type of acute treatment option for people living with the debilitating pain and other symptoms of migraine," said David Nicholson, EVP and Chief R&D Officer, Allergan. "Its oral administration with two dose strengths allows for treatment flexibility and relief when a migraine attack occurs. As we continue to drive innovation in migraine treatment, we are very proud to offer patients another option, and we are confident that it will make a difference for those in need. At Allergan, we believe that migraine patients deserve access to all new medications for this debilitating disease." About UBRELVYâ„¢ (ubrogepant) The FDA approval for UBRELVYâ„¢ is based on four clinical studies (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002), which demonstrated efficacy, safety and tolerability of orally-administered UBRELVYâ„¢ in the acute treatment of migraine. The two pivotal Phase 3 clinical trials (ACHIEVE I and ACHIEVE II) established the safety and efficacy profile of UBRELVYâ„¢. Both 50 mg and 100 mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, compared with placebo. Nausea was the most common adverse event reported in 1.7-4.1% of patients at various doses during the pivotal studies, compared to 1.6-2.0% of patients who received placebo. There were no serious adverse events within 48 hours of a dose. Additionally, the safety study (UBR-MD-04) reinforced the long-term safety and tolerability of UBRELVYâ„¢ for both the 50 mg and 100 mg dose strengths. Our research shows that UBRELVYâ„¢ was well tolerated with an adverse event profile similar to placebo. Visit www.ubrelvy.com for more information. UBRELVYâ„¢ will be available in the first quarter of 2020. About Migraine INDICATION UBRELVYTM (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults. UBRELVYâ„¢ is not indicated for the preventive treatment of migraine. IMPORTANT SAFETY INFORMATION Contraindication: Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin). Adverse Reactions: The most common adverse reactions were nausea (4%) and somnolence (3%). Please see link to full Prescribing Information. About Allergan plc With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day. For more information, visit Allergan's website at www.Allergan.com. About Allergan MINDâ„¢ Forward-Looking Statement CONTACTS: Allergan: Investors: Media: Lisa Brown Julie Ciardiello View original content:http://www.prnewswire.com/news-releases/allergan-receives-us-fda-approval-for-ubrelvy-for-the-acute-treatment-of-migraine-with-or-without-aura-in-adults-300979082.html SOURCE Allergan plc | ||
Company Codes: NYSE:AGN |
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