2020-01-09| Trials & Approvals

Ubrelvy Approval, the Best New Year Gift for CGRP Migraine Victims

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

The FDA approval of a new migraine drug in the final week of December 2019 came as a perfect New Year’s gift for approximately 31 million Americans and other migraine victims around the world.

Migraine is the second leading cause of disability worldwide and the third most common disease, affecting more than 10% of the global population. Migraines are triggered by a number of factors such as stress, hormonal changes, insomnia, and bright lights. Common symptoms include nausea, vomiting, intense throbbing or pulsating pain in one area of the head and sensitivity to light and sound.

On December 23rd, Allergen’s Ubrelvy (ubrogepant) received approval from the USFDA for the acute treatment of migraine with or without aura in adults. Ubrelvy specifically targets the calcitonin gene-related peptide (CGRP), a protein released during migraine attacks, by blocking its binding to the receptor. This way, it effectively focuses on one known cause with very few side effects. The drug has been evaluated by the testimonies of multiple parties, including paid consultants and R&D officers at Allergen, clinical trial patients, and the FDA’s Center for Drug Evaluation & Research. Ubrelvy is soon expected to enter the market and is estimated to generate $302 million USD by 2024.

Clinical Trial Data

Four clinical trials (ACHIEVE I, ACHIEVE II, UBR-MD-04 and 3110-105-002) played a key role in the FDA approval of Ubrelvy. The two critical Phase 3 clinical trials (ACHIEVE 1 and II), demonstrated that 50mg and 100mg dose strengths of Ubrelvy significantly reduced more pain and bothersome migraine-associated symptoms for two hours as compared to placebo. Designing the study with two different dosages in mind aims to give healthcare providers the opportunity to personalize treatment approaches for their specific patients.

Adverse Effects of Ubrelvy

The studies demonstrated that Ubrelvy has no serious adverse events within 48 hours of a dose. In fact, the trials discovered only a higher occurrence of nausea in some patients. 1.7~4.1% of patients who were administered with Ubrelvy reported nausea at various dosages, higher than 1.6~2.0% of those administered with placebo. The difference between the nausea occurrence rates is slightly higher in the drug arm but pales in comparison to earlier treatment which was known to constrict blood vessels.

Evaluations & Anticipations Based on Testimonies

Ubrelvy is the first and only orally-administered CGRP receptor antagonist for the treatment of migraine attacks. Therefore, it is given high evaluation and anticipation from several parties of interest.

“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.” In addition, Allergen’s consultant Dr. Peter Goadsby, Neurologist and Professor at King’s College, London, and University of California, San Francisco echoed Nicholson’s claim by saying that “I can offer my migraine patients a new treatment option that may work for them.”

Besides, a patient and an FDA representative also affirmed the potential of Ubrelvy. “As someone living with migraine for 14 years, my life seems to be on pause when I experience a migraine attack,” said Kristin Molacek, a clinical trial participant. “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.”

Billy Dunn, M.D., acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, expressed great potential for Allergen’s product: “Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication. The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies.”




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