FDA approves Ubrelvy (ubrogepant) for the acute treatment of migraine

Allergan plc recently announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Ubrelvy 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.

"The FDA's approval of Ubrelvy, 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, Ubrelvy provided quick pain relief for the majority of migraine patients. Ubrelvy™ 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.

Ubrelvy provided lasting relief up to 24 hours as well. Ubrelvy 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.

Ubrelvy 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, Ubrelvy clinical trial patient. "During the clinical trial, my experience with Ubrelvy 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 Ubrelvy is now approved by the FDA. As the first oral gepant, Ubrelvy 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 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.

It works in a new way by blocking 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. CGRP receptor antagonism is a completely new mechanism of action for the acute treatment of migraine.

The FDA approval for Ubrelvy 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 Ubrelvy 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 Ubrelvy.

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 Ubrelvy for both the 50 mg and 100 mg dose strengths. Our research shows that Ubrelvy was well tolerated with an adverse event profile similar to placebo.

About Migraine
Migraine is a neurological disease with episodic attacks defined by symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. There has long been a need for new treatments for migraine with improved benefit-risk profiles as compared to current standard of care.

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 (e.g., ketoconazole, itraconazole, clarithromycin).

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

 

FDA approves Ubrelvy (ubrogepant) for the acute treatment of migraine

Allergan plc recently announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Ubrelvy 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. The FDAs approval of Ubrelvy, 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 Kings 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 FDAs approval, Ubrelvy provided quick pain relief for the majority of migraine patients. Ubrelvy 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. Ubrelvy provided lasting relief up to 24 hours as well. Ubrelvy 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. Ubrelvy 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, Ubrelvy clinical trial patient. During the clinical trial, my experience with Ubrelvy 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 Ubrelvy is now approved by the FDA. As the first oral gepant, Ubrelvy 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 RD 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 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. It works in a new way by blocking 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. CGRP receptor antagonism is a completely new mechanism of action for the acute treatment of migraine. The FDA approval for Ubrelvy 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 Ubrelvy 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 Ubrelvy. 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 Ubrelvy for both the 50 mg and 100 mg dose strengths. Our research shows that Ubrelvy was well tolerated with an adverse event profile similar to placebo. About Migraine Migraine is a neurological disease with episodic attacks defined by symptoms such as headache pain, sensitivity to light and sound, and nausea. Migraine is highly prevalent, affecting approximately 31 million Americans, and is associated with significant disability leading to high personal, family, occupational, societal, and economic burden. There has long been a need for new treatments for migraine with improved benefit-risk profiles as compared to current standard of care. 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 (e.g., ketoconazole, itraconazole, clarithromycin). Adverse Reactions: The most common adverse reactions were nausea (4%) and somnolence (3%).