FDA Expands AbbVie's (ABBV) Qulipta Label in Chronic Migraine
AbbVie ABBV announced that the FDA has approved the label expansion of its migraine drug Qulipta (atogepant) at 60mg dose to include the prevention of chronic migraine in adults.
Following the approval, Qulipta is now the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic migraines.
Qulipta was initially approved by the FDA in 2021 for the preventive treatment of episodic migraine in adults at three different dose levels — 10 mg, 30 mg and 60 mg.
People living with episodic migraine get fewer than 15 headaches in a month while those with chronic migraine experience headaches for at least 15 days a month.
In the year so far, shares of AbbVie have dropped 0.3% against the industry‘s 2.5% rise.
The label-expansion approval is based on the data from the phase III PROGRESS study, which evaluated a 60mg dose of Qulipta in adult patients with chronic migraine. The study met its primary endpoint of Qulipta achieving a statistically significant reduction in mean monthly migraine days from baseline compared with a placebo over a 12-week treatment period.
Data from the PROGRESS study also showed that treatment with Qulipta also achieved all of its six secondary endpoints, including a minimum of 50% reduction in mean monthly migraine days and improvements in function and reduction in activity impairment.
Apart from Qulipta, AbbVie already has two other drugs — Botox (onabotulinumtoxinA) and Ubrelvy (ubrogepant) — approved by the FDA to treat migraine in adults. Botox is approved in the United States for the preventive treatment of chronic migraine while Ubrelvy is approved for the acute treatment of migraine attacks with or without aura. Per management, AbbVie is the only company that has three drugs designed to meet patient needs across the full spectrum of migraine.
AbbVie faces stiff competition from Pfizer PFE, which has two approved CGRP drugs in the migraine-treatment space. Last October, Pfizer acquired Biohaven’s oral CGRP business, following which it acquired Nurtec ODT (rimegepant), an FDA-approved drug for acute treatment of migraine with or without aura in adults and preventive treatment of episodic migraine. Last month, the FDA approved Pfizer’s nasal spray Zavzpret (zavegepant) for acute treatment of migraine with or without aura in adults.
In a separate press release, AbbVie also announced that its blockbuster inflammatory drug Rinvoq (upadacitinib) has received label expansion approval in the European Union for a seventh indication — Crohn’s disease. The drug is already for six indications, including rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, ankylosing spondylitis, atopic dermatitis and ulcerative colitis.
April 19, 2023