Teva Presents Ajovy Data from European Real World Evidence Program
8 November 2021 - - Israeli generic and specialty pharmaceutical company Teva's (NYSE: TEVA) Teva Germany business presented at the DGN Congress 2021 the first interim analysis results of the FINESSE study aiming to provide real-world evidence of fremanezumab treatment outcomes by evaluating effectiveness in routine clinical practice, the company said.

97.6% of patients included in the study had already received preventive migraine therapies in the 10 years prior to study entry, including antidepressants, anticonvulsants, beta-blockers, ca-antagonists, onabotulinumtoxinA as well as other anti-CGRP mAbs.

The interim analysis results were shared in a poster presentation at the congress by Prof. Andreas Straube, from Ludwig-Maximilians University Munich, Germany, who is the principal investigator of the study.

The presented FINESSE interim data1 indicate that real-world response rates are consistent with Phase-III-study results of fremanezumab.

The primary endpoint measure was the proportion of patients reaching ≥ 50% reduction in the monthly average number of migraine days evaluated during the 6-month period after the first dose of fremanezumab.

48.7% of the patients with 6-month data achieved the primary endpoint, with a higher %age in EM (53.2%) than CM patients (43.0%). Real-world response rates are thus in line with Phase-III-study results of fremanezumab.

The mean number of migraine days per month decreased from 12.7 (baseline) to 6.2 (month 6).

From baseline to month 6, the mean MIDAS Score decreased from 74.8 at baseline to 32.8 and the mean HIT-6 Score from 65.9 at baseline to 56.6

FINESSE is a 49-month (25-month recruitment and 24-month follow-up) multicenter, two-country (Germany/Austria), prospective observational study.

Eligible patients are adults (≥ 18 years) diagnosed with EM or CM who have been prescribed fremanezumab according to the Summary of Product Characteristics.

The primary endpoint is the proportion of patients reaching ≥ 50% reduction in the monthly average number of migraine days evaluated during the 6-month period after the first dose of fremanezumab.

Relevant secondary effectiveness endpoints include changes from baseline in: (1) Monthly average number of migraine days; (2) Disability scores; (3) Days of acute migraine medication use per month.

Effectiveness data is evaluated using data from patient diaries and patient-reported outcome measures (disability scores).

Recruitment of the FINESSE study is still ongoing.

Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. Ajovy is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or a pre-filled pen.

Two dosing options are available:225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections.

Ajovy can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.