Israeli pharma Teva has hit its endpoints in the phase 3 Halo study of fremanezumab in migraines as it looks to send off a BLA to the FDA in the coming months.
Looking at the data, patients treated with fremanezumab saw a statistically significant reduction in the number of monthly headache days (of at least moderate severity) when pitted against a dummy treatment (-2.5 days) during the 12-week period after first dose, for both monthly (-4.6 days) and quarterly (-4.3 days) dosing regimens.
Those on fremanezumab also saw a "significant improvement" compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability, Teva says in a statement.
“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Michael Hayden, M.D., Ph.D., president of global R&D and CSO at Teva.
“Our phase 3 clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine. We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”
Based on these data, Teva is plotting to send on a new Biologics License Application to the U.S. regulator “later this year.”
More topline data from the med are also expected in the “coming weeks” from another phase 3 test, this time in episodic migraine.
The drug, a monoclonal antibody targeting the CGRP ligand, is not the only one of its kind. Novartis and Amgen are also at work on erenumab, itself an antibody to calcitonin gene-related peptide (CGRP), with analysts at Bernstein predicting this class could grow into a $6 billion category at peak.
Amgen is considered to be in pole position in the market, although it recently gave away a sizable chunk of its marketing rights to Novartis as some analysts saw a dip in the sales potential of these meds as more therapies are poised to enter the market, which include Teva, as well as Eli Lilly and Alder Biopharmaceuticals.
All of these experimental meds have shown similar efficacy in previous late-stage testing, completely eliminating migraines in 10% to 20% of patients and cutting attacks in half in more than 50%.