Teva says fremanezumab showed clinically and statistically significant improvements in all endpoints.
Teva is heralding more promising news regarding its migraine-prevention drug, fremanezumab.
The Jerusalem-based pharmaceutical company announced in a news release earlier this week that the treatment showed strong results in its second phase III HALO study. The episodic migraine (EM) study involved patients who were treated monthly and quarterly with the drug. The study showed statistically and clinically significant improvements in all endpoints, as well as in 12 pre-specified analyses.
Trial participants reported a mean of 9.1 monthly migraine headaches and 39 days of impairment due to migraines each month. Teva reports that fremanezumab, administered as a monthly injection, decreased the number of migraines by 41.6%. That percentage represents 3.7 fewer days, compared to 2.2 fewer days in the placebo group. These study participants also saw a 64.7% decrease in the number of days their migraines left them disabled. Medication consumption decreased by 39.0%.
Researchers also tested the efficacy of the drug in a group that received a quarterly dosage. Teva says this group saw highly significant results, citing a 37% decrease in migraine days, which translates to 3.4 fewer days.
The research team noted that members of the test group who were on other migraine medications while receiving fremanezumab also saw migraine improvement: 4 fewer days for the monthly dose, compared to 2 fewer in the placebo group; 3.7 fewer days for participants who received fremanezumab quarterly.
According to Teva, the drug met all other pre-specified analyses. Injection site pain was the most common adverse event that participants reported.
Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva called the findings “a major advance on existing data.”
“The efficacy and rapid onset, as both add-on and monotherapy, quarterly dosing, and effect on disability and quality of life indicate that this therapy has the potential to set new and different benchmarks in the relief of migraine suffering,” Hayden said.
Teva says it will offer more detailed findings in the coming months in peer-reviewed journals and at scientific meetings, including trial results pertaining to chronic migraines at the American Headache Society Annual Scientific Meeting, taking place today through Sunday, June 11, and at the Congress of the International Headache Society later this year.
Teva says it will apply for a Biologics License Application with the U.S. Food and Drug Administration (FDA) later this year in episodic and chronic migraine. The company expects to receive FDA approval and launch the drug in the second half of 2018.
The announcement comes on the heels of more positive fremanezumab news, announced earlier this month. Teva said that the drug significantly reduced the rate of monthly moderate-severity headaches in a placebo-controlled, 16-week trial. The results were shown in monthly and quarterly doses. This trial included 1,130 participants.
MD Magazine writer Kevin Kunzmann contributed to this report.