One of the gems AbbVie inherited from the $63 billion Allergan transaction is ready to take a slice of the highly competitive migraine market—and no, it’s not Botox.
The New England Journal of Medicine published results from a phase 3 clinical trial of atogepant for preventing migraines Thursday. Oral atogepant was found to reduce the number of migraine and headache days per month over a treatment period of 12 weeks. AbbVie has already send off the therapy for FDA review, with a decision expected in the coming months.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a neuropeptide, or a small protein produced by the neurons, that is suspected to play an integral role in migraine. As the understanding of the CGRP relationship to migraine became better understood in neuroscience, so too did the ability to find drugs that could target it and potentially relieve the painful and debilitating condition.
Allergan is positioning atogepant to be among the first oral medicines to prevent migraine in a crowd of injectable drugs. SVB Leerink sees AbbVie cracking off about $1.2 billion of the market in peak sales. AbbVie itself anticipates sales of $1 billion; either way, that's a blockbuster number.
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“Migraine prevention hasn’t been dominated by any of the injectable medicines, and we expect the orals to take share from the injectables, and to expand the market,” SVB Leerink said.
That’s because the top therapies have fairly comparable efficacy and large numbers of patients simply don’t respond, according to SVB Leerink. So patients tend to shuffle between a few before they find something that works for them.
The once-daily, oral delivery mechanism could help atogepant differentiate in a crowded field of competitors that includes Eli Lilly’s Emgality, Amgen’s Aimovig, Biohaven’s Nurtec, Teva’s Ajovy and finally, Lundbeck’s Vyepti. Emgality, Aimovig, Nurtec, Ajovy and Vyepti are approved to prevent migraines. Nurtec is an oral therapy.
While AbbVie's drug is easier to take, patients may have to contend with a high rate of constipation that was found in clinical trials, SVB Leerink said in a note. This could impact the duration of treatment and the order in which doctors offer the therapy to patients. The adverse events, which were mild to moderate during the trial, should be manageable by physicians.
SVB Leerink expects that atogepant will get the OK from the FDA for preventing episodic migraines by the September deadline. AbbVie is also examining the therapy in chronic migraine prevention. A data readout for that study is expected in 2022.
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“Given the results in episodic migraine, and the efficacy results of other CGRP’s in chronic migraine, we expect the chronic trial to be successful,” SVB Leerink said.
Atogepant will, of course, join Allergan’s crown jewel, Botox, in AbbVie’s migraine program. The north Chicago, Illinois-based Big Pharma also has another CGRP inhibitor called Ubrelvy approved for acute migraine treatment, which SVB Leerink expects will bring in $542 million in 2021. that number is expected to rise to over a billion by 2024. The oral medicine is currently approved for acute treatment but no preventive indications.
With a large salesforce and market position already established, AbbVie should have no trouble moving atogepant once approved.