AbbVie’s Atogepant NDA Submissions

On 30 March, the FDA accepted AbbVie’s new drug application (NDA) for atogepant for the preventive treatment of migraine.

Atogepant is a member of the gepant class of drug and is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRPs are potent vasodilators, particularly in the cerebral circulation. The release of CGRP within the trigeminal nucleus caudalis facilitates activation of nociceptive second-order neurons and glial cells, which leads to the pain associated with migraines. Atogepant is administered orally, which is a key attribute that will significantly strengthen AbbVie’s position in the migraine market over the coming years.

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The NDA approval was supported by data from a pivotal Phase III ADVANCE multi-center clinical trial in patients who experienced four to 14 migraine episodes per month, a pivotal Phase IIb/III study, and a Phase III long-term safety study. In the ADVANCE study, investigators found a greater than 50% reduction in the mean monthly migraine days over a 12-week treatment period, achieving the key primary and secondary endpoints of the study. This mirrored the positive results of the Phase IIb/III study in episodic migraine patients. Findings from the Phase III safety study, where the patients received atogepant daily for 52 weeks, will be presented by AbbVie next month at the American Academy of Neurology 2021 Virtual Annual Meeting.

Atogepant is set to compete with CGRP monoclonal antibodies (mAbs), Amgen’s erenumab, Eli Lilly’s galcanezumab, Teva’s fremanezumab, and Lundbeck’s eptinezumab. While these drugs are effective prophylactic migraine treatments, their production costs as reflected in their high pricing may act as a barrier to uptake.

Atogepant offers positive clinical attributes including oral administration, an alternative to mAbs that require intravenous infusions and monitoring by a doctor. With these considerations, atogepant presents a more cost-effective and convenient option to reduce the mean number of migraine days for patients. GlobalData forecasts that atogepant will generate annual global revenue of $766m in 2026.

Within the same drug class, AbbVie’s Ubrelvy (ubrogepant) and Biohaven’s Nurtec (rimegepant) have both obtained approval in the US for acute migraine treatment, in December 2019 and February 2020 respectively. With efforts to enter the prophylactic market segment, Biohaven has submitted a marketing authorization application (MAA) and a supplemental new drug application (sNDA) for Nurtec as a preventive treatment of migraine. The applications have been accepted for review by the European Medicine Agency (EMA) and FDA, respectively. However, atogepant is anticipated to have the first-to-market advantage over Nurtec as an oral prophylaxis migraine treatment.

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The potential approval of atogepant will expand AbbVie’s portfolio of marketed migraine therapeutics, which consists of Ubrelvy and Botox (onabotulinumtoxin A). Botox is prescribed for the prevention of headaches in adults diagnosed with chronic migraine. Ubrelvy is used for acute migraine treatment and has not been investigated for migraine prevention. However, the entrance of atogepant to the market enables AbbVie to play a significant role in the prophylactic segment for episodic migraine.