Qulipta™ (atogepant), AbbVie Inc.

Qulipta™ (atogepant), AbbVie Inc.
Jacqueline Scholler, PD4, University of Minnesota

Indication: Prevention of episodic migraines in adults. 

Mechanism of Action: Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. When CGRP is released in excess, it causes intense pain and inflammation in the meninges. Atogepant works by blocking the release of CGRP, thus, preventing the underlying mechanism of migraine attacks. 

Dosage and Administration: Atogepant is given as a 10mg, 30mg, or 60mg once daily oral tablet with or without food. For patients with severe renal impairment or concomitant strong CYP3A4 inhibitor use, the dose is 10mg orally once daily. Its use should be avoided in patients with severe hepatic impairment. For patients with concomitant OATP inhibitor use, the dose is 10 or 30mg orally once daily. The dose is 30 or 60mg orally once daily for patients on moderate to strong CYP3A4 inducers. 

Effectiveness: In the first efficacy trial done to evaluate atogepant, 910 patients were randomized to receive atogepant 10mg, 30mg, 60mg, or placebo once daily for 12 weeks. The primary efficacy endpoint was the change from baseline in mean monthly migraine days (MMD). The mean change from baseline MMD across 12 weeks was -3.7 days for atogepant 10mg, -3.9 for atogepant 30mg, -4.2 for atogepant 60mg, and -2.5 for placebo (p<0.001 for all three atogepant arms). 

Safety: In the 12-week clinical trials for atogepant, the most common adverse effects reported were nausea, constipation, and fatigue. The events had an incidence rate that was at least 4% greater than placebo. Decreased appetite was another reported adverse event, however, the difference in incidence between placebo and the atogepant arms was not significant. 

Cost: The average wholesale price (AWP) for 30 tablets of any strength (10mg, 30mg, or 60mg) is $1,189 according to RED BOOK online.

Place in Therapy: Atogepant is a once daily oral tablet approved as first-line therapy to prevent chronic migraines in adults.This is currently the only available oral option for CGRP receptor antagonists. In addition to easier administration, this medication has shown efficacy and tolerability in clinical trials. However, it may only be available to certain patient groups due to its steep cost. 

References:

  1. QULIPTA™ (atogepant) | Episodic Migraine Preventive Treatment. Qulipta.com. https://www.qulipta.com. Published 2021. Accessed November 8, 2021.
  2. Rxabbvie.com. https://www.rxabbvie.com/pdf/qulipta_pi.pdf?_ga=2.218844761.1763905657.1.... Published 2021. Accessed November 8, 2021.
  3. Episodic Migraine Preventive Treatment | QULIPTA™ (atogepant) HCP. Quliptahcp.com. https://www.quliptahcp.com. Published 2021. Accessed November 10, 2021.
  4. Active Ingredient: Atogepant. RED BOOK Online. IBM Micromedex [database online]. Truven Health Analytics/IBM Watson Health; 2021. Accessed November 19, 2021. https://www.micromedexsolutions.com.