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Teva Pharmaceuticals Presents Data on Efficacy and Safety of Fremanezumab

May 13, 2019
12-month study demonstrates reduced monthly chronic and episodic migraine attacks

A PPM Brief

Teva Pharmaceutical (Petah Tikva, Israel) announced1 results from long-term analyses of the efficacy and safety of fremanezumab, presented at the 2019 Meeting of the American Academy of Neurology (AAN) in Philadelphia, PA from May 4 to 10, 2019. Fremanezumab (brand name: AJOVY) is an injection indicated for the preventive treatment of migraine in adults.

The findings describe data and endpoints from a 52-week, multicenter, randomized, double-blind, parallel group long-term extension study that evaluated fremanezumab in adults with migraine, observed through 12 months of treatment, including populations with inadequate responses to multiple classes of preventive medications.

(Source: 123RF)

Patients were assigned to monthly dosing (225 mg monthly; chronic migraine starting dose = 675 mg), or quarterly dosing (675 mg every three months). A total of 1,890 patients were enrolled and 1,494 completed the 12 months of treatment. Patients included those with chronic migraine (CM) and episodic migraine (EM):

  • In the CM study, an analysis of 1,110 patients saw those achieving ≥50% reduction in monthly average number of headache days of at least moderate severity at month 12 was 54% of patients in the quarterly dosing arm and 59% in the monthly dosing arm. Those achieving ≥50% reduction in monthly average number of migraine days at month 12 was 53% of patients in the quarterly dosing arm and 57% of patients in the monthly dosing arm. Additionally, patients with CM showed decreased use of any acute headache medication and improvements in disability.
  • In the EM study, an analysis of 780 patients demonstrated that patients achieving ≥50% reduction in migraine days at month 12 was 66% in the quarterly dosing arm and 68% in the monthly dosing arm. Similar response rates were observed for headache days of at least moderate severity. Patients with EM also showed decreased use of any acute headache medication and improvements in disability.

A safety analysis of those enrolled in the one-year study demonstrated that the most common adverse events were injection-site reactions, which occurred in 26 to 33% of all patients (4% discontinued due to adverse events).

The company also conducted a post-hoc efficacy analysis of 813 patients with CM at baseline, of which 548 (67%) reverted to EM during the study period:

  • The average change in the monthly number of headache days of at least moderate severity from baseline to month 12 was -8.8 for the quarterly dosing arm and -8.5 for the monthly dosing arm.
  • The mean change in the monthly number of migraine days from baseline to month 12 was -10.3 for the quarterly dosing arm and -10.4 for the monthly dosing arm.

“These data, studied in a wide range of migraine patient populations, add to our growing body of evidence about fremanezumab, and further demonstrate our ongoing commitment to improving the lives of those who suffer from migraine,” said Danny McBryan, senior vice president and head of global medical affairs and pharmacovigilance at Teva Pharmaceuticals.

Last updated on: June 14, 2019
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