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Allergan gets FDA nod for first oral CGRP drug for migraine

Extended use into acute treatment of migraine


Allergan has claimed the prize of becoming the first company to get FDA approval for an oral CGRP inhibitor, extending the use of these drugs into the acute treatment of migraine.

The US regulator has given a green light to Ubrelvy (ubrogepant) for acute migraine with or without aura, and Ireland-domiciled Allergan says it intends to launch the drug in the first quarter of 2020, although there’s no word yet on pricing.

The approval is also a boost for AbbVie, which agreed a $63bn takeover of Allergan earlier this year but has faced criticism of the deal centred mainly on a lack of late-stage pipeline prospects at the Irish company.

Ubrelvy joins a handful of injectable, antibody-based CGRP inhibitors that have been approved for migraine prevention – dosed every few weeks in order to reduce the chances of attacks taking place – and now provides an option for treating attacks once they have already begun.

First to market among these the injectables was Amgen/Novartis’ Aimovig (erenumab), and it has since been joined by Eli Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab), with intravenous eptinezumab from Alder Biopharma – now owned by Lundbeck – in late-stage development.

“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,” commented Billy Dunn, acting head of the FDA’s Office of Neuroscience, who notes that there are around 37m people in the US who suffer from migraines.

The CGRP inhibitors offer hope to patients with acute migraine who can't get relief from the current array of therapies, which consists of pain-killing drugs and triptans. Analysts say Ubrelvy offers triptan-like pain relief with an improved safety profile, and could be an option for an estimated four million people in the US with migraine who do not respond to or cannot tolerate triptan drugs.

Ubrelvy’s closest CGRP rival is Biohaven’s late-stage candidate rimegepant, which could join it on the market next year, and it also faces competition from Lilly’s Reyvow (lasmiditan), the first in a new class for serotonin 5-HT1F agonists for acute migraine which was approved in the US in October.

Meanwhile, Allergan also has an oral CGRP inhibitor in late-stage development for migraine prevention – called atogepant – and is expecting results in the second half of 2020.

Analysts have suggested that Allergan’s oral CGRP franchise could generate blockbuster sales, addressing a market that could be worth as much as $4bn a year, drawing on the company’s established presence in migraine prevention with Botox.

Atogepant is expected to account for the bulk of Allergan’s sales in the franchise, with Ubrelvy tipped to be a $500m product by 2025.

Article by
Phil Taylor

24th December 2019

From: Regulatory



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