Teva to present long-term efficacy, safety data on fremanezumab at AAN 2019

Teva Pharmaceutical Industries announced results from new long-term analyses of the efficacy and safety of fremanezumab, being presented at the 71st Annual Meeting of the American Academy of Neurology.The findings, presented across 13 abstracts at this year’s meeting, describe the primary and other key endpoints, as well as pooled and subgroup data from a 52-w eek, multicenter, randomized, double-blind, parallel group long-term extension study that evaluated fremanezumab in adults with migraine. The results presented include data on the efficacy of fremanezumab observed through 12 months of treatment in patients with migraine, including populations with inadequate responses to multiple classes of preventive medications, quality of life and the safety profile. In an analysis of the 1,110 patients included in the study with CM, those achieving greater than or equal to50 percent reduction in monthly average number of headache days of at least moderate severity at month 12 was 54 percent of patients in the quarterly dosing arm and 59 percent in the monthly dosing arm. Those achieving greater than or equal to50 percent reduction in monthly average number of migraine days at month 12 was 53 percent of patients in the quarterly dosing arm and 57 percent of patients in the monthly dosing arm. Additionally, patients with CM showed decreased use of any acute headache medication and improvements in disability that were observed through the one-year treatment period. An analysis of the 780 patients included in the study with EM demonstrated that patients achieving greater than or equal to50 percent reduction in migraine days at month 12 was 66 percent in the quarterly dosing arm and 68 percent in the monthly dosing arm. Similar response rates were observed for headache days of at least moderate severity. Similar to the results observed in CM patients, patients with EM also showed decreased use of any acute headache medication and improvements in disability that were observed through the one-year treatment period. Additionally, Teva conducted a post-hoc efficacy analysis of 813 patients with CM at baseline, of which 67 percent reverted to EM during the study period. In this subgroup, 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 quarterly and -10.4 for monthly. Overall, monthly headache days, migraine days and days of acute headache medication use decreased progressively from month six and through month 12 in both dosing groups. A safety analysis of all 1,890 patients enrolled in the one-year study demonstrated that the most common adverse events were injection-site reactions, which occurred in 26-33 percent of all patients. Four percent of patients discontinued due to adverse events. Teva also assessed whether patients in the quarterly dosing arm experienced any pattern of decreased efficacy during the third month after injection. In the analysis of 1,103 CM patients and 775 EM patients, outcomes with quarterly dosing of fremanezumab were comparable to outcomes with monthly dosing. The effect of fremanezumab on headache-related disability, quality-of-life and patient satisfaction in CM and EM patients was assessed using clinically validated questionnaires. Overall, long-term treatment with fremanezumab suggested potential improvements in disability and quality of life in patients with both CM and EM.

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