Qulipta, a medication containing atogepant, received FDA approval for the preventive treatment of episodic migraine in adults on September 27, 2021 [1]. This approval marked a significant development in migraine treatment, offering a new oral option targeting the calcitonin gene-related peptide (CGRP) pathway [2].
What is Qulipta used for?
Qulipta (atogepant) is indicated for adults who experience episodic migraine, a condition characterized by migraine headaches occurring on 14 or fewer days per month [1].
How does atogepant work to prevent migraines?
Atogepant is a CGRP receptor antagonist [2]. CGRP is a molecule implicated in migraine pathophysiology. By blocking the action of CGRP, atogepant is believed to reduce the inflammation and vasodilation associated with migraine attacks [3].
What were the clinical trials for Qulipta approval?
The FDA approval was based on two Phase 3 studies, the ADVANCE trial and the progress trial [1]. The ADVANCE trial demonstrated a statistically significant reduction in monthly migraine days compared to placebo in participants treated with Qulipta [4].
When does Qulipta patent expire?
Information regarding the specific patent expiry dates for Qulipta can be found on specialized databases. For example, DrugPatentWatch.com tracks patent information for pharmaceuticals, including expiry dates and litigation [5].
Who manufactures Qulipta?
Qulipta is manufactured by AbbVie [1].
What are the potential side effects of Qulipta?
Common side effects reported in clinical trials include upper respiratory tract infection, nausea, and fatigue [1].
Are there other oral CGRP inhibitors for migraine prevention?
Yes, other oral CGRP receptor antagonists have been approved for migraine prevention, such as Ubrelvy (ubrogepant) and Nurtec ODT (rimegepant). These medications, like Qulipta, target the CGRP pathway [6].
How does Qulipta compare to injectable CGRP treatments?
Injectable CGRP pathway inhibitors, such as Aimovig (erenumab-aooe), Ajovy (fremanezumab-vfrm), and Emgality (galcanezumab-gnlm), are also available for migraine prevention. These are administered via injection, whereas Qulipta is an oral medication [7]. The choice between oral and injectable treatments often depends on patient preference and response [8].
What is the typical dosage and administration for Qulipta?
Qulipta is taken orally once daily, with or without food [1].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-2021-fda-approvals
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-other-actions
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa2025502
[4] https://www.mayoclinic.org/drugs-supplements/atogepant-oral-capsule/id/D06473
[5] https://drugpatentwatch.com/
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8419755/
[7] https://www.neurologyadvisor.com/topics/migraine/what-is-calcitonin-gene-related-peptide-cgrp-and-how-it-works-in-migraine-treatment/
[8] https://www.mdedge.com/neurology/article/244410/migraine/qulipta-atogepant-new-oral-cgrp-antagonist-migraine-prevention