FDA Approves AbbVie’s Migraine-Prevention Drug Qulipta

AbbVie’s Qulipta Set to Become Blockbuster in the Migraine Market. On September 28, AbbVie announced that the FDA approved Qulipta (atogepant) 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. Blockade at the CGRP receptors prevents the activation of trigeminal fibres that exacerbate vasodilation and cause neurogenic inflammation, which is thought to lead to the headache and pain response felt in migraines.

Atogepant migraine drug molecule (CGRP inhibitor). Skeletal formula.  Векторный объект Stock | Adobe Stock

In the preventive market, beta-adrenergic receptor blockers, calcium antagonists, antidepressants and anti-epileptics are drug classes prescribed to reduce the number of migraine days. Unfortunately, many of these oral preventive treatments have a poor efficacy profile and have been associated with potential adverse events or are contraindicated, which may interfere with concurrent conditions and treatments. While monoclonal antibodies (mAbs) against CGRP have been marketed for migraine prophylaxis and present an effective preventative treatment of migraine, 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) and 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 associated 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.

Nevertheless, barriers to Qulipta uptake do exist as it is likely to compete with Biohaven’s Nurtec (rimegepant). Following its approval in 2020 for acute treatment, Nurtec received label expansion in May 2021 allowing for preventive treatment in episodic migraine patients. Between the oral gepants, Nurtec’s every-other-day dosing provides the advantage of reducing the number of treatment days in comparison to Qulipta’s daily dosing schedule. However, Nurtec’s less-frequent dosing schedule could impair compliance in patients, as it may be difficult for patients to track medication days and breaks. Furthermore, KOLs reported that Qulipta’s efficacy profile and its availability of multiple-dose formulations, from 10mg to 60mg, had a competitive edge over Nurtec.

Currently, there is an ongoing trial to determine the efficacy of Qulipta for the prevention of chronic migraine, patients who experience 15 or more headaches per month (NCT03855137). The study will be conducted at 169 locations, including in the US, Europe and Japan. The estimated primary completion date is in February 2022. GlobalData anticipates that Qulipta will launch in the EU in Q1 2023 and forecasts that it will generate global sales of $1.2bn by 2027. September 30th, 2021

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