Ubrelvy FDA approval : Irish pharma company Allergan has bagged approval from the US Food and Drug Administration (FDA) for Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura in adults.
Aura is a sensory phenomenon or visual disturbance.
Ubrelvy is now the first orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) to be approved by the FDA for the treatment of migraine attacks after their onset. It has not been indicated for the preventive treatment of migraine.
Commenting on Ubrelvy FDA approval, David Nicholson – EVP and Chief R&D Officer of Allergan, said: “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.
“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.”
Ubrelvy’s effectiveness for the acute treatment of migraine was shown in a couple of randomized, double-blind, placebo-controlled clinical trials featuring 1,439 adult patients with migraine history, with and without aura. The enrolled patients were subjected to the approved doses of Ubrelvy for the treatment of an ongoing migraine.
In both the clinical trials, the percentages of patients who had pain freedom two hours following the treatment and whose most bothersome migraine symptom stopped two hours post-treatment were greater among patients receiving Ubrelvy at all doses by a significant extent in comparison to those who were under placebo.
Patients were permitted to have their usual acute treatment of migraine at least two hours after having Ubrelvy, of which 23% of them were on preventive medication for migraine.
Billy Dunn – acting director of the Office of Neuroscience in the FDA Center for Drug Evaluation and Research, commenting on Ubrelvy FDA approval, said: “Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.
“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.”
Ubrelvy is said to function in a new way by preventing the CGRP protein released during a migraine attack from binding to its receptors. The drug works without constricting blood vessels, which is otherwise the case with some older treatments.