by Jessica Ailani, MD, FAHS, FAAN

The migraine treatment landscape has expanded over the last several years with targeted treatments with novel mechanisms of action coming to market.  Medications targeting calcitonin gene related peptide (CGRP) have been shown to be effective for both the prevention and acute treatment in migraine (1) and are often described as “life changing” by patients.  With novel treatments comes the challenge of observing adverse events that were either predicted or were unanticipated (2,3).  Within the CGRP treatment space, recent safety updates to one CGRP targeted treatment, Erenumab, have caused many clinicians to focus on safety data for new drugs (4). 

Atogepant, a small molecule CGRP receptor antagonist (gepant) is being evaluated for the prevention of migraine (5).  A prior gepant, telcagepant, while under investigation for migraine prevention was found to cause liver function changes in a cohort of subjects (6).  The current study, by Chris Min et al, evaluates daily dosing of Atogepant for 28 days and its impact on liver enzymes.  This is an important study to confirm liver safety in a gepant that will be used daily.  The results report a low risk of liver injury with enzyme changes being similar in both the treatment group and placebo.  These results provide evidence on the safety of Atogepant for daily use.  Longer-term safety studies are needed to confirm these findings and pharmacovigilance would be needed after FDA approval if new side effects or concerns arise. 

Atogepant providers patients an oral disease specific treatment for the prevention of migraine.  This allows patients flexibility in choosing the right option for their disease.  This data allows clinicians to converse about safety concerns with patients and allows a modicum of ease when prescribing Atogepant.

 

References

1. Edvinsson L. (2019). Role of CGRP in migraine. In Calcitonin Gene-Related Peptide (CGRP) Mechanisms (pp. 121-130). Springer, Cham.
2. Deen M, Correnti E, Kamm K, et al.  (2017). Blocking CGRP in migraine patients–a review of pros and cons. The journal of headache and pain, 18(1), 96.
3. Silberstein SD, Reshef S, Cohen JM, et al. (2020). Adverse Event Profiles of Therapies that Target the Calcitonin Gene-Related Peptide (CGRP) Pathway, During the First Six Months After Launch: A Real-world Data Analysis Using the FDA Adverse Events Reporting System (FAERS)(4315).
4. https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/aimovig/aimovig_pi_hcp_english.ashx.  Accessed 8/6/2020.
5. Goadsby PJ, Dodick DW, Trugman JM, et al. (2019). Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study (s17. 001).
6. Ho TW, Connor KM, Zhang Y, et al. (2014). Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology, 83(11), 958-966.