AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
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There was new hope on Tuesday for millions of migraine sufferers as AbbVie announced the U.S. Food and Drug Administration (FDA) acceptance of its New Drug Application (NDA) for atogepant, which aims to prevent the often debilitating condition.
Migraine is a neurological disorder, the intensity of which can vary wildly between its victims. It is classically characterized by intense headaches, nausea, difficulty speaking and sensory disturbances called aura which can include flashes of light and blind spots.
Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist which works by mitigating the elevated levels of this peptide, which have been shown to be elevated during migraine attacks.
“With the results from these trials, we aim to provide a safe and effective preventive treatment that offers patients and healthcare providers a simple, once daily oral treatment that works specifically by blocking CGRP receptors and preventing migraine,” said AbbVie Senior Vice President of R&D and Chief Scientific Officer, Thomas J. Hudson, MD, in a statement after the company announced earlier Phase III data.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2,500 adult participants who experience them between 4-14 days per month.
During a 12-week treatment period, all atogepant dose groups – 10mg, 30mg, and 60mgs respectively – achieved an ascending reduction of 3.69, 3.86, and 4.2 migraine days compared to the placebo group, which experienced a decrease of just 2.48 days, a statistically significant recovery of quality time.
Even more impressive, 58.7% and 60.8% of patients in the 30 and 60mg dose range enjoyed at least a 50% reduction of mean migraine days compared to only 29% of those in the placebo arm.
“We believe atogepant is an advancement with the potential to offer meaningful benefits as a safe, effective oral preventive treatment option. Despite the availability of other migraine treatment options, the medical community and people living with migraine recognize the unmet need of those who face the unpredictable and debilitating realities of this disease,” said AbbVie Vice President, Neuroscience Development, Michael Gold, MD.
From a safety standpoint, Atogepant was well-tolerated, with the most common adverse events being constipation, nausea, and upper respiratory tract infection, which were all mild-to-moderate in the majority of participants.
Atogepant belongs to the portfolio of drugs that came over to AbbVie when it expanded its presence in the Neuroscience space with the acquisition of Allergan Inc., finalized in May 2020.
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