Date: 2017-06-08
Type of
information: Results
phase: 3
Announcement: results
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. CGRP levels rise during a migraine attack and normalize when the attack goes away.
- AMG 334 is 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 has commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization rights in Europe and the rest of the world.
Disease: migraine
Therapeutic
area: CNS diseases
Country: Austria, Belgium, Canada, Czech Republic, Finland, Germany, Netherlands, Poland, Slovakia, Sweden, Turkey, UK, USA
Trial
details: The STRIVE study is a phase 3, randomized, stratified, double-blind, placebo-controlled, parallel-group, multi-center study followed by active-treatment phase to evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days. (NCT02456740)
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. Results from STRIVE have been submitted for peer-reviewed publication.
- 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 November 16, 2016, Novartis and Amgen announced topline results from the global Phase III STRIVE study, evaluating the efficacy and safety of the fully human monoclonal antibody AMG 334 (erenumab) in episodic migraine prevention. Once-monthly subcutaneous AMG 334 was evaluated at 70mg and 140mg doses, with both doses meeting the study's primary endpoint, demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months versus placebo.
Patients enrolled in STRIVE were randomized to receive either placebo, or one of two AMG 334 doses, 70mg or 140mg, subcutaneously, once monthly, for six months. Patients experienced between four and 14 migraine days each month, with an average of 8.3 migraine days per month at baseline. Over the last three months of the double-blind treatment phase, patients in the 70mg and 140mg AMG 334 treatment arms experienced a statistically significant 3.2-day and 3.7-day reduction from baseline in mean monthly migraine days, respectively, as compared to a 1.8-day reduction in the placebo arm.
The safety profile of AMG 334 was comparable to placebo across both treatment arms over the six-month double-blind evaluation. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and sinusitis.
Further analysis of the STRIVE data is ongoing. Positive results from ARISE, the first Phase III study of AMG 334 in episodic migraine prevention, and results from a Phase II study of AMG 334 in chronic migraine prevention, were announced earlier this year. These data will help support discussions with regulatory agencies, with filing anticipated in 2017.
- • 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
