Teva Pharmaceutical has reported that its migraine drug fremanezumab had succeeded in its phase 3 HALO studies by meeting all its 25 primary and secondary endpoints.
The Israeli pharma firm said that fremanezumab showed statistically significant and clinically meaningful results in the phase 3 studies in chronic (CM) and episodic migraine (EM).
It added that the endpoints of the late-stage HALO studies were met in both monthly and quarterly dosing regimens.
Teva CMO & specialty clinical development head Marcelo Bigal said: “The statistically significant results from the CM and EM trials across multiple measures of migraine burden, including improvement in quality of life and disability, highlight the potential of fremanezumab to provide patients with meaningful relief.
“After validating the target for CM and EM in the Phase II clinical trials, we are thrilled to present these results to the migraine community, providing a deeper view into the pivotal trial design and full results of the HALO program.”
According to Teva, fremanezumab is a fully-humanized monoclonal antibody that acts against the calcitonin gene-related peptide (CGRP) ligand, which is considered to be a well-validated target in migraine treatment.
Teva says that given the limited preventive treatment options for migraine, fremanezumab can turn out to be a potential new option to cover a significantly unmet medical need.
The Israeli pharma company had presented results from the phase 3 CM and EMI studies to the International Headache Society (IHC) in Canada.
Teva will prepare to file a Biologics License Application (BLA) for fremanezumab in the US later in the year, said Teva vice president & therapeutic area head, R&D, migraine and headache Ernesto Aycardi.