Teva presented Phase 3 data evaluating their investigational migraine treatment fremanezumab at the 18th Congress of the International Headache Society (IHC). The Company indicated they plan to use the data to file a Biologics License Application (BLA) later this year.
The Phase 3 HALO studies comprised of 2 separate patient populations. A total of 875 with episodic migraine (EM) and 1,130 patients with chronic migraine (CM) were enrolled. Both groups were randomized 1:1:1 to receive either 225mg subcutaneous fremanezumab monthly for 3 months, 675mg of fremanezumab at initiation followed by placebo for 2 months (quarterly doses), or 3 months of placebo only. The primary endpoint of the EM study was the mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose.
Results demonstrated that at 12 weeks after the first dose of fremanezumab, the CM group had reductions of monthly headaches; -4.6 days for the monthly dose, -4.3 days for the quarterly dose and -2.5 for the placebo group (P<0.0001).
The EM group also had reductions; -3.7 days for the monthly dose, -3.4 for the quarterly dose, and -2.2 for the placebo group (P<0.0001).
Additionally, fremanezumab also showed superiority to placebo in measures of activity impairment outside of work for the quarterly dose, with a treatment difference of -4.0%±1.85% (P=0.0311) for the CM group. For the EM group, there was also a significant reduction in the number of monthly days of acute headache medication use: -3.0 days for the monthly dose and -2.9 days for the quarterly dose vs. -1.6 days for placebo (P<0.0001).
The most commonly reported adverse event in the episodic and chronic migraine trials was injection site pain, with similar rates in the placebo and active groups.
Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP ligand. “With our full CM and EM pivotal results presented to the migraine community, we now look forward to filing a BLA in the U.S. later this year, bringing us one step closer to potentially bringing a new, preventive migraine treatment option to patients,” said Ernesto Aycardi, MD, VP at Teva.
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