AbbVie has recently announced that Qulipta (atogepant) has received FDA approval for the preventive treatment of episodic migraine in adults. Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. The market for oral prophylactic treatments to reduce the number of migraine days holds great potential says GlobalData. The leading data and analytics company, anticipates that Qulipta will launch in the EU in Q1 2023 and forecasts that it will generate global sales of $1.2bn by 2027.
Christie Wong, Pharma Analyst at GlobalData comments: “Beta adrenergic receptor blockers, calcium antagonists, antidepressants, and anti-epileptics are all drug classes to reduce the number of monthly migraine days. Many of these drugs have a poor efficacy profile and are associated with adverse events. While monoclonal antibodies (mAbs) against CGRP have been marketed for migraine prophylaxis and present an effective preventive treatment of migraine, however, some patients do not respond well to the mAbs or have a needle phobia.”
Qulipta has a considerably shorter half-life in comparison to the monthly dosing schedule of mAbs Amgen’s Aimovig (erenumab), Eli Lilly’s Emgality (galcanezumab) and quarterly administration offered by Teva’s Ajovy (fremanezumab) and Lundbeck’s Vyepti (eptinezumab). As such, there is a higher risk of non-compliance with a daily oral pill that is less likely to be observed with the mAbs.
However, key opinion leaders (KOLs) interviewed by GlobalData perceived the short wash-out period of gepants as an advantage for populations of migraine patients that require termination of CGRP treatment, for example, in cases where patients had a stroke or heart attack, or they got pregnant.
Currently, there are ongoing trials to determine the efficacy of Qulipta for the prevention of chronic migraine, in patients who experience 15 or more headaches per month (NCT03855137) with an estimated primary completion date of February 2022.
Wong adds: “Qulipta is likely to compete with Biohaven’s Nurtec (rimegepant), which following its approval in 2020 for acute treatment, received label expansion in May 2021, allowing for preventive treatment in episodic migraine patients. KOLs reported that Qulipta’s efficacy profile and its availability of multiple dose formulations, from 10 mg to 60 mg, had a competitive edge over Nurtec.”