Oral CGRP inhibitors made by AbbVie and Biohaven Pharmaceuticals are quickly gaining share in the migraine market. But unlike their injectable peers, the two oral options have their prevention labels limited to episodic patients. That might change soon.
AbbVie’s oral CGRP med Qulipta topped placebo at reducing monthly migraine days when used as a preventative treatment for patients with chronic migraine in a phase 3 trial, the Illinois pharma said Thursday.
With the latest data, AbbVie plans to file an application with the FDA as well as other regulators to expand Qulipta’s use. If approved, a label for preventive treatment of chronic migraine could give AbbVie a leg up in an ongoing tussle for oral CGRP market leadership against Biohaven’s earlier-to-market Nurtec ODT. Within the preventative setting, both drugs are currently only cleared for episodic migraine.
The phase 3 Progress study tested Qulipta in migraine patients who experienced headache on 15 or more days per month. AbbVie conducted two slightly different analyses to cater to patient population definitions by regulators in the U.S. and EU.
In the U.S. analysis, patients on Qulipta 60-mg once daily and 30-mg twice daily experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, across the trial’s 12-week period. That compared with a decrease of 5.05 days for the placebo arm.
Based on the EU criteria, the monthly decreases were 6.75 days and 7.33 days for 60-mg once daily and 30-mg twice-daily Qulipta, respectively. The placebo group recorded a decrease of 5.09 monthly migraine days.
The clinical trial has therefore met its main goal. Both dosing regimens also hit statistically significant improvements in all secondary endpoints. On one secondary endpoint, the U.S. analysis showed that 41% and 42.7% of patients in the 60-mg once-daily and 30-mg twice-daily Qulipta arms enjoyed at least a 50% reduction in average monthly migraine days, versus 26% for placebo.
Nurtec had previously tried to land a broad prevention label to cover both episodic and chronic patients. But the FDA granted a go-ahead in May 2021 that only included episodic patients. Biohaven’s pivotal clinical trial enrolled less than 20% of migraine patients who had at least 15 migraine days per month.
At that time, Biohaven management and SVB Leerink analyst Marc Goodman shrugged off the restriction, quoting a mere 5% share of chronic patients in the overall migraine group. Besides, many patients fluctuate between episodic and chronic migraine, according to Biohaven.
AbbVie is looking at the chronic migraine market differently. The disease impacts 1% to 2% of the global population, according to the Big Pharma, and people with frequent, more severe migraines, such as chronic migraine sufferers, receive half of all preventative migraine prescriptions.
The limited FDA labels didn’t seem to stop doctors from using Qulipta or Nurtec off-label for the prevention of migraine in chronic patients. In a survey of 103 U.S. neurologists or headache specialists conducted by Spherix Global Insights in the fourth quarter, Nurtec already captured 8.4% share among chronic migraine patients in the prevention setting, up from 5% in the third quarter, Piper Sandler analyst Christopher Raymond said in a January note. Qulipta, which became available in October, scored a 1.4% share in chronic migraine.
Nurtec comes with the convenience of being able to treat migraine in both prevention and acute settings. As for Qulipta, AbbVie designed it to specifically tackle preventative treatment, while its sister oral CGRP med Ubrelvy is intended to treat sudden migraine attacks.
AbbVie has projected both Ubrelvy and Qulipta could reach over $1 billion in peak sales. During an investors’ call last month, AbbVie president Michael Severino said the company plans to file Qulipta in chronic migraine prevention this summer and expects an FDA decision in the first half of 2023.
Meanwhile, the oral CGRP drugs also need to compete with injectables such as Amgen’s Aimovig and Eli Lilly’s Emgality, which have broader prevention labels coving chronic patients.