AbbVie wins FDA approval for new migraine indication

Published: Apr 19, 2023

By Tristan Manalac

BioSpace

The FDA has approved an expanded indication for AbbVie’s Qulipta (atogepant) to treat patients with chronic migraine, the company announced Tuesday.

Qulipta is now the only oral CGRP receptor antagonist approved as a preventive treatment for both episodic and chronic migraine frequencies, AbbVie stated in its press release. The drug won its first approval in September 2021 for episodic migraine.

The FDA based its expanded approval on data from AbbVie’s pivotal Phase III PROGRESS trial, which enrolled 778 patients with chronic migraine, defined as having experienced at least 15 headache days per month for more than three months. Qulipta was given orally once a day at 60 mg.

Patients treated with Qulipta saw a significant decrease in their average monthly migraine days across 12 weeks of treatment compared to placebo. Qulipta also met all six secondary endpoints in PROGRESS, including better functioning and lower impairment of activity due to migraine.

Qulipta’s safety profile in PROGRESS is consistent with its profile in patients with episodic migraine. Common adverse events included fatigue and sleepiness, constipation and nausea.

These data show that Qulipta effectively and safely eases the burden of headaches in patients with chronic migraine, leading to high response rates and sustained improvements in function, Peter McAllister, director of the New England Center for Neurology and Headache, said in a statement.

Qulipta also comes in a once-daily oral formulation, making it a convenient option for patients.

“These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine,” McAllister said.

CGRP Competition in the Migraine Market

Tuesday’s label expansion makes AbbVie the only pharma company with three approved treatments across the migraine spectrum, Roopal Thakkar, senior vice president and chief medical officer at AbbVie, said in a statement.

The company’s migraine arsenal also includes Botox (onabotulinumtoxinA), a preventive treatment for chronic migraine, and Ubrelvy (ubrogepant), an acute option for migraine.

One of AbbVie’s biggest competitors in the migraine market is Pfizer, which owns Nurtec ODT (rimegepant), an oral drug approved in 2020, and Zavzpret (zavegepant), a nasal spray approved in March. Pfizer gained access to both drugs in 2022 when it bought the original developer, Biohaven, for $11.6 billion.

Like Qulipta, Nurtec ODT and Zavzpret are antagonists of the CGRP receptor. In migraine, CGRP is released in the brain and can affect a nerve called the trigeminal nerve, Ilan Danan, sports neurologist and pain management specialist at the Center for Sports Neurology and Pain Medicine, Cedars-Sinai Kerlan-Jobe Institute, told Healthline.

CGRP can also affect blood vessels, which leads to other symptoms associated with migraine, Danan said.

Unlike Qulipta, however, both of Pfizer’s migraine assets are indicated only for acute treatment. This difference could help AbbVie establish a stronger foothold for its drug in the migraine space.

In 2022, AbbVie’s migraine assets earned more than $3 billion in revenue, most of which was from Botox, which sold $2.25 billion. Ubrelvy and Qulipta each brought in $680 and $158 million, respectively.

Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at [email protected] or [email protected]

Source: BioSpace