Data for Aimovig from OLE trial and STRIVE trial for migraine to be presented at American Academy of Neurology meeting

Amgen has announced that it will present new long-term data of Aimovig (erenumab-aooe) across the migraine spectrum at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia . Data from a one-year open-label extension (OLE) trial following a three-month double blind study in patients with chronic migraine (15 or more headache days per month) showed sustained efficacy and safety in this patient population, including a potential for conversion to episodic migraine (4-14 headache days a month). Additionally, one-year results of the Phase III STRIVE study reinforced the sustained efficacy and safety profile of Aimovig in patients with episodic migraine, including patients who had tried and failed prior preventive treatments.

Data in Chronic Migraine- An exploratory analysis of one-year OLE data from the pivotal study evaluating the efficacy and safety of Aimovig in chronic migraine prevention assessed the conversion rate from chronic to episodic migraine. The results at 52 weeks showed more than two-thirds of patients with chronic migraine on Aimovig converted to episodic migraine by the last dose received. Patients converting to episodic migraine showed a reduction of 11 monthly migraine days (MMD) at week 52, from a baseline of 17 MMD. Both doses had high conversion rates, with the Aimovig 140 mg dose numerically higher (76 percent) compared to Aimovig 70 mg (69 percent) Further data from the study evaluating the long-term efficacy and safety results of Aimovig in patients with chronic migraine during open-label treatment are being presented at AAN.

Data in Episodic Migraine- One-year results of the Phase III STRIVE study (including 24-week double-blind phase and 28-week active treatment phase [ATP]) showed Aimovig provided sustained efficacy in the prevention of episodic migraine and a safety profile comparable to that observed in prior studies. At week 52, patients receiving Aimovig 70 mg or 140 mg from week 24 onward had an average of 4.2 and 4.6 fewer MMD, respectively, compared to study baseline (8.3 MMD). They also continued to experience improvements during the ATP (1.1 and 1.8 fewer MMD, respectively). In addition, an analysis of responder rates from baseline showed more than six out of 10 patients on either dose of Aimovig had 50 percent fewer MMD; around four out of 10 had 75 percent fewer MMD; and one in five were migraine-free at week 52. Additional data from STRIVE and the OLE phase of the LIBERTY study in patients taking Aimovig with episodic migraine who had failed prior preventive treatments are being presented at AAN.

About the Open-Label Extension Study in Chronic Migraine- The OLE of the pivotal parent study (NCT02066415) was a 52-week, multicenter study (OLE, NCT02174861) evaluating the long-term efficacy and safety of Aimovig in chronic migraine prevention in patients taking Aimovig 70 mg and 140 mg. Patients initially enrolled received 70 mg of Aimovig monthly. The protocol was amended for patients to receive 140 mg of Aimovig. Patients who had completed the week-28 visit at the time of the amendment continued to receive Aimovig 70 mg, and patients who had enrolled but had not completed the week-28 visit at the time of the amendment increased from 70 mg to 140 mg of Aimovig at the next visit such that these patients would have the opportunity to receive at least six months of Aimovig 140 mg during the 52-week study. All patients who enrolled after the amendment received Aimovig 140 mg throughout the study. Proportions of episodic migraine converters/nonconverters based on observed data were summarized throughout the OLE (overall population) and by last dose received (70 mg or 140 mg). Efficacy data were collected at weeks 1-12, 21-24, 37-40, and 49-52; endpoints included change from parent study baseline in monthly migraine days (MMD) and proportion of patients with =50 percent reduction from parent study baseline in MMD.

About STRIVE - STRIVE (Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention, NCT02456740)- is a global Phase III, multicenter, randomized 24-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in episodic migraine (characterized in this study as =4 to <15 migraine days per month and <15 headache days per month on average across the three months before screening) prevention. In the study, 955 patients were randomized to receive once-monthly subcutaneous placebo, or Aimovig (70 mg or 140 mg) in a 1:1:1 ratio. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline. The primary endpoint was change in mean monthly migraine days from baseline over the last three months of the double-blind treatment phase of the study (months 4, 5 and 6). Secondary study endpoints assessed included reduction of at least 50 percent from baseline in mean MMD, change from baseline in mean monthly acute migraine-specific medication days, and changes from baseline in both mean impact on everyday activities domain and mean physical impairment domain scores on the Migraine Physical Function Impact Diary (MPFID). At week-24 (ATP baseline), 845 patients were re-randomized (1:1) to Aimovig 70 mg or 140 mg for the subsequent 28-week dose-blinded ATP. Assessments included MMD; monthly acute migraine-specific medication days (MSMD); proportion of patients achieving a =50 percent, =75 percent, and 100 percent reduction in MMD (responder rates: RR); and safety.