Teva’s AJOVY shows promising results in migraine prevention Phase IV study

New interim analysis from the pan-European PEARL Phase IV study reveals that Teva Pharmaceutical Industries’ AJOVY (fremanezumab) has led to a significant reduction in monthly migraine days for almost 60% of patients.

The migraine prevention drug also showed sustained improvement in disability scores and acute medication use over 12 months.

The data further show that fremanezumab is effective not only in preventing migraine attacks in patients with chronic and episodic migraine, but also in reducing the severity and duration of remaining attacks. These findings were announced today and are set to be discussed further at the 9th European Academy of Neurology (EAN) Congress in Budapest, Hungary.

The PEARL (Pan-European Real World study) is a two-year prospective, observational study evaluating the effectiveness of AJOVY (fremanezumab) in 1,140 patients with chronic or episodic migraine. Fremanezumab is a humanised monoclonal antibody that selectively targets the calcitonin gene-related peptide (CGRP) pathway.

Of the study’s participants, data from 968 patients were available for the third interim analysis. It was observed that 58.5% of these patients saw a 50% or more reduction in their monthly migraine days following 12 months of treatment.

Pinar Kokturk — Teva Pharmaceutical Industries Vice President and Head of Medical Affairs Europe said: “The 3rd interim analysis of the PEARL study provides valuable insights for clinicians and patients into the effectiveness of fremanezumab (AJOVY) in a real-world setting.

“Real-world data allows us to bridge the gap between scientific evidence and the complexities of real-life scenarios, offering a comprehensive understanding of how treatments truly impact patients’ lives. The PEARL study is particularly relevant to clinicians due to its large patient cohort, coming from 11 countries across Europe.”

AJOVY is currently indicated for the prophylaxis of migraine in adults who experience at least 4 migraine days per month. The drug is available in a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. There are two available dosing options, which are 225 mg once monthly (monthly dosing) or 675 mg every three months (quarterly dosing).