A Phase III study of fremanezumab from Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) yielded positive results. A chronic migraine (CM) study of the investigational treatment, which is used to prevent migraines, was in the final experimental stage before being submitted to the Food and Drug Administration for approval.
About 1,130 patients were enrolled in the randomized CM study and categorized in 376 patients per treatment group. In a ratio of 1:1:1 injections of fremanezumab at 675 mg at initiation were administered first. This was followed by monthly 225 mg for two months then by placebo for two months.
Teva plans to submit a Biologics License Application
During the 12-week period after the first dose of fremanezumab, the primary efficacy endpoint was impressive with reduced numbers of headache days of at least moderate severity. It is also expected that in the coming weeks, Teva’s Phase III HALO will report top line results in the study Episodic Migraine (EM).
Both the CM and EM studies are carried out for 16-weeks and the main goal is to compare the safety, permissibility, and efficacy of four dose regimens of subcutaneous fremanezumab. Given the success in the CM Teva is ready to submit a BLA to the U.S. Food and Drug Administration (FDA) for fremanezumab.
The progress of the differentiated clinical development program
The top-line results demonstrate how well the differentiated clinical development program is progressing according to Head of Specialty Clinical Development at Teva, Marcelo Bigal. It is worth noting that close to more than 38 million Americans experience migraines, which is a serious, debilitating neurological condition.
Nonetheless, Bigal says, “These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine.”
Echoing the progress, the company’s Vice President & Therapeutic Area Head, R&D, Ernesto Aycardi explained that their primary goal is to have more details that would benefit the migraine community. Furthermore, there has been an inadequate availability of preventive treatment options for migraine. Thus fremanezumab is expected to fill in the gap of the unmet needs.
In the meantime, Teva’s stock closed at $27.86 witnessing an increase of $0.04 or 0.14%.
