Patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days for both monthly and quarterly dosing regimens.
Matthias Mueller, MD, MSc
The phase 3b FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adults who previously experienced inadequate responses to 2 to 4 classes of preventive treatments produced positive topline results demonstrating the effectiveness of the therapy, Teva announced.
In the study, participants treated with fremanezumab experienced a highly significant reduction in the monthly average number of migraine days (primary endpoint) versus placebo (-0.6 days) throughout the 12-week period for both monthly, (-4.1 days, P <.0001) and quarterly (-3.7 days, P <.0001) dosing regimens.
“With robust effect sizes for the primary endpoint, the FOCUS trial produced clinically meaningful results that demonstrated the effectiveness of fremanezumab in a population of patients that are difficult to treat and who require other treatment options,” Matthias Mueller, MD, MSc, vice president global medical affairs, head of therapeutic areas and scientific communications, Teva, said in a statement.1 “We look forward to bringing forward additional insights from the study in the future.”
FOCUS (NCT03308968) evaluated the efficacy, safety and tolerability of monthly and quarterly subcutaneous injections of fremanezumab compared to subcutaneous injections of placebo in 838 study participants with chronic migraine or episodic migraine who have responded inadequately to 2—4 classes of prior therapies. Inadequate response was defined as a lack of efficacy after at least 3 months of therapy; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the particular patient.
Participants were randomized 1:1:1 into 1 of 3 treatments for the subgroup (2 active treatments and 1 placebo) consisting of a quarterly dosing regimen, monthly dosing regimen or matching placebo. Those treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens.
Secondary endpoints included the mean change from baseline in the number of headache days of at least moderate severity at 4 weeks; the mean change from baseline in the monthly average number of migraine days at 4 weeks; the proportion of patients reaching at least a 50% reduction in the monthly average number of migraine days at 4 and 12 weeks; the mean change from baseline in the monthly average number of headache days of at least moderate severity at 12 weeks; the mean change from baseline in the monthly average number of days of use of any acute headache medications at 12 weeks; the percentage of patients who did not complete study due to adverse effects; and the percentage of participants with adverse events at the end of the study.
All study participants have continued into an open-label extension of 3 months (weeks 13—24) where participants are administered subcutaneous injections of fremanezumab at weeks 12, 16 and 20.
In the United States, fremanezumab is marketed as Ajovy and indicated for the preventive treatment of migraine in adults. It’s available as a 225 mg/1.5 mL single dose injection in a prefilled syringe with 2 dosing options, 225 mg administered monthly as 1 subcutaneous injection, or 675 mg every 3 months administered as 3 subcutaneous injections. There’s no starting dose required to begin treatment. Fremanezumab is the first and only anti-calcitonin gene-related peptide (CGRP) therapy that’s approved with monthly and quarterly dosing options.
There were no safety signals detected in the study, but the most common adverse reactions greater than 5% are injection site reactions.
Teva plans to submit the full phase 3b study results for upcoming medical meetings as well as peer-reviewed publication in 2019.
Announces Positive Topline Phase IIIb Results with Fremanezumab in Adults with
Who Did Not Respond to Multiple Classes of Preventive Treatments [news release]. Jerusalem: Teva Pharmaceutical Industries; Dec. 17, 2018. https://www.tevapharm.com/news/teva_announces_positive_topline_phase_iiib_results_with_fremanezumab_in_adults_with_migraine_who_did_not_respond_to_multiple_classes_of_preventive_treatments_12_18.aspx?rel=0" ?rel=0" . Accessed Dec. 18, 2018.