Under the strategic neuroscience collaboration between Novartis (NVS) and Amgen’s (AMGN), Aimovig became the first drug in the research pipeline for which a Biologics License Application has been filed with the FDA.
Novartis and Amgen would jointly commercialize Aimovig in the United States. However, Amgen retains the right to exclusively market the drug in Japan. Novartis would retain exclusive rights in Europe, Canada, and the rest of the world.
Phase 3 STRIVE trial
In November 2018, Amgen presented positive results from the Phase 3 STRIVE trial. Amgen conducted the Phase 3 STRIVE trial to evaluate the safety and efficacy of Aimovig compared to placebo for the prevention of episodic migraine.
In the Phase 3 STRIVE trial, Aimovig demonstrated a clinically meaningful and statistically significant difference from placebo for all primary and secondary endpoints of the trial.
In the clinical trial, patients on Aimovig experienced a substantial decrease in mean monthly migraine days. Patients on Aimovig were more likely to achieve a 50.0% or more decrease in monthly migraine compared to patients on placebo therapy.
Based on the Migraine Physical Function Impact Diary (or MPFID), patients receiving Aimovig reported substantial improvements in fundamental measures assessing the effect of migraine on their lives.
After the FDA’s approval, Aimovig became the first and only fully human monoclonal antibody that specifically inhibits the CGRP (calcitonin gene-related peptide), which plays an important role in triggering the migraine.
In the Phase 3 STRIVE trial, patients on Aimovig demonstrated a 3.7-day decrease in monthly migraine days compared to 1.8 days for patients on placebo therapy.
In the STRIVE trial, patients on Aimovig 140 mg and Aimovig 70 mg demonstrated decreases of 1.6 days and 1.1 days, respectively, in the use of acute or “rescue” migraine-specific medication compared to 0.2 days for patients on placebo therapy.
In the clinical trial, as a secondary endpoint, Aimovig 140 mg and Aimovig 70 mg demonstrated clinically meaningful reductions of 5.9 points and 5.5 points, respectively, in the effect of migraine on patients’ daily activities.
The superior results from the STRIVE clinical trial are expected to strengthen Aimovig’s commercialization profile.
Amgen comprises ~1.7% of the PowerShares QQQ ETF’s (QQQ) total portfolio holdings.