Allergan builds case for migraine drug ubrogepant as FDA verdict nears

Allergan’s ubrogepant could become the first oral drug in the new CGRP inhibitor class if it is approved by the FDA in December, but is still facing a challenge in the market.

The US regulator’s decision will be based on phase 3 data – just published in the Journal of the American Medical Association – which show that the drug is more effective than placebo at alleviating migraine-related pain.

Injectable, antibody-based CGRP inhibitors like Amgen’s Aimovig (erenumab) and Teva’s Ajovy (fremanezumab) have been approved for migraine prevention, but with its oral therapy Allergan plans to extend the use of the class into treatment of acute migraine attacks.

If the FDA does approve the drug, ubrogepant will however have to compete head-to-head against Eli Lilly’s new acute migraine drug Reyvow (lasmiditan), a first-in-class serotonin 5-HT1F receptor agonist which was cleared last month.

In the ACHIEVE II study published in JAMA, ubrogepant at both 25 mg and 50 mg doses was more effective than placebo at ridding patients of pain two hours after dosing, while the higher dose was also better at freeing them from their most bothersome migraine symptoms at that time point.

Migraines are associated with excruciating headache but can also cause sensitivity to light and sound, visual disturbances and nausea/vomiting.

So far, despite lacklustre efficacy of existing migraine drugs for prevention and treatment, such as triptans and epilepsy drugs like topiramate, the take-up of the injectable CGRP therapies has been a little sluggish.

That has been put down to payer resistance as they are so much more expensive than current, generic migraine drugs.

Market research firm GlobalData says first-to-market Aimovig – which was approved in 2018 – could become a $1.4 billion-plus product in 2026, but has been growing slowly and brought in $66 million for Amgen in the third quarter of this year.

Ajovy was approved later in 2018 but its sales didn’t warrant a mention in Teva’s third-quarter update, while third-to-market Emgality (galcanezumab) from Eli Lilly – the only drug to have approval in cluster headache prevention as well as migraine – made $48 million in the three-month period.

GlobalData has predicted 2024 sales of Ajovy and Emgality of $500 million and $1 billion, respectively.

Allergan has previously suggested that ubrogepant for acute migraine and follow-up atogepant – a phase 3 candidate that may offer a once-daily oral alternative to the CGRP antibody drugs for migraine prevention – could combine to generate multibillion-dollar sales.

The company says it will be able to draw on its experience with wrinkle treatment Botox - also used for migraine prevention - to drive take-up of the new drugs if approved.

Both oral CGRP inhibitors were acquired from Merck & Co/MSD, after the latter abandoned its lead candidate telcagepant several years ago.