Approval of Ubrelvy follows several new migraine drugs.
FDA okayed the first acute migraine drug in the class of oral calcitonin gene-related peptide receptor antagonists.
Allergan received the approval for its ubrogepant (Ubrelvy) tablets to treat acute migraine with or without aura in adults. The medication is not indicated for the preventive treatment of migraine.
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“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,” said Billy Dunn, MD, acting director of the Office of Neuroscience in FDA’s Center for Drug Evaluation and Research, in a statement from FDA. “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.”
Migraine drug approvals have accelerated in 2018 and 2019. In late 2018, FDA approved galcanezumab-gnlm (Emgality, Eli Lilly and Company) 120 mg injection for the preventive treatment of migraine in adults, soon after giving the greenlight to fremanezumab-vfrm (Ajovy, Teva) injection, an anti-calcitonin gene-related peptide receptor (CGRP-R) treatment for the prevention of migraine with quarterly and monthly dosing options.
The effectiveness of Ubrelvy was demonstrated in two randomized, double-blind, placebo-controlled trials. More than 1,400 adult patients with a history of migraine, with and without aura, received the approved doses of Ubrelvy to treat an ongoing migraine.
In both studies, the percentages of patients achieving pain freedom 2 hours after treatment (defined as a reduction in headache severity from moderate or severe pain to no pain) and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped 2 hours after treatment were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo.
Twenty-three percent of patients were taking a preventive medication for migraine.
The most common side effects that patients in the clinical trials reported were nausea, tiredness and dry mouth, FDA said.