Date: 2017-06-08
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 59th Annual Scientific Meeting of the American Headache Society
Company: Amgen (USA - CA) Novartis (Switzerland)
Product: AMG 334 (erenumab)
Action
mechanism:
- monoclonal antibody. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits Calcitonin-Gene-Related-Peptide (CGRP) by targeting its receptor, rather than CGRP itself, which is believed to transmit signals that can cause incapacitating pain. AMG 334 is currently under investigation in several large global, randomized, double-blind, placebo-controlled studies to evaluate its safety and efficacy in migraine prevention.
- In August 2015, Novartis entered into a global collaboration with Amgen to commercialize and develop new treatments in the field of Alzheimer's disease and migraine, including AMG 334 (currently in phase III studies for episodic migraine and a phase II study for chronic migraine) and AMG 301 (currently in a phase I study for migraine). As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and the rest of the world.
Disease: migraine
Therapeutic
area: CNS diseases
Country: Denmark, France, Greece, Portugal, Russian Federation, Spain, Switzerland, USA
Trial
details:
- The ARISE study is a global Phase III, multicenter, randomized 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of AMG 334 in episodic migraine prevention. In the study, 577 patients were randomized to receive once-monthly subcutaneous placebo or AMG 334 (70mg) in a 1:1 ratio. Patients enrolled in ARISE were experiencing between four and 14 migraine days each month.The primary endpoint was change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with episodic migraine (the number of migraine days between weeks nine and 12). Secondary study endpoints included the proportion of patients with a reduction of at least 50% from baseline in monthly migraine days and change from baseline in monthly acute migraine-specific medication days in the last four weeks of the double-blind treatment phase. The impact of migraine on physical function and the impact on everyday activities were each assessed as secondary endpoints by the Migraine Physical Function Impact Diary (MPFID), a scale developed to measure these two domains. (NCT02483585)
Latest
news:
- • On June 8, 2017, Novartis and Amgen presented detailed results of STRIVE and ARISE, two Phase III studies of erenumab in people with 4 to 14 migraine days per month. Detailed results from the positive 6 month STRIVE study of erenumab 70mg and 140mg, and the positive 3 month ARISE study of erenumab 70mg will also be presented at the meeting. These data include both primary and secondary endpoints, evaluating the reduction in monthly migraine days and the percentage of patients who responded to erenumab. The safety profile of erenumab was similar to placebo across all treatment arms in the Phase 2 and Phase 3 studies. The most common adverse events across the studies were upper respiratory tract infection, injection site pain, nausea and nasopharyngitis.
- • On September 28, 2016, Novartis announced positive topline results from ARISE, the first Phase III study evaluating the efficacy and safety of monthly subcutaneous AMG 334 (erenumab) 70mg in episodic migraine prevention. The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with AMG 334 compared with placebo at 12 weeks.
A total of 577 patients enrolled in ARISE were randomized to receive either placebo or AMG 334 at 70mg subcutaneously, once monthly. Patients experienced between four and 14 migraine days each month, with an average of eight migraine days per month at baseline. Those receiving AMG 334 experienced a statistically significant 2.9-day reduction from baseline in monthly migraine days, as compared to a 1.8-day reduction in the placebo arm. The safety profile of AMG 334 was similar to placebo and consistent with previously-reported studies. The most common adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis.
Further analysis of the ARISE data is ongoing, and will be submitted to a future medical meeting and for publication. The STRIVE study, a second Phase III episodic migraine study evaluating both 70mg and 140mg doses of AMG 334 for 24 weeks, is expected to be completed by the end of this year. Positive results from a Phase II study of AMG 334 in chronic migraine prevention were also announced earlier this year.
- • On June 8, 2016, Novartis announced that the company is also evaluating AMG 334 in two ongoing phase III studies in episodic migraine, with initial data from these studies expected later this year.
Is
general: Yes
