Amgen ($AMGN) and Novartis’ ($NVS) migraine drug erenumab has hit the primary endpoint in a Phase II trial. The mid-phase success raises the possibility that Amgen will file for approval following the upcoming readout from a Phase III trial of the drug, a timeline that could see it snag a regulatory nod ahead of rival products from Eli Lilly ($LLY) and Teva ($TEVA).
This week’s data drop comes from a Phase II trial that assessed erenumab, also known as AMG 334, as a prevention of chronic migraines. The 667 participants in the study received either one of two once-monthly injected doses of erenumab--70 mg or 140 mg--or a placebo. Following 12 weeks of treatment, Amgen assessed the change in monthly migraine days. Having experienced 18 migraine days a month at baseline, patients in the treatment arm reported having fewer than 12 days a month at the end of the trial.
The 6.6-day reduction in the treatment cohort bested the 4.2-day drop seen in the placebo arm. That gap was statistically significant, resulting in Amgen hitting its primary endpoint. A lack of data on the performance of erenumab against other endpoints in the top-line release means questions about how the results compare with those generated by rival products are outstanding, though. Notably, Amgen is yet to say how erenumab performed against a secondary endpoint that tracked the proportion of subjects to achieve at least a 50% reduction from baseline in monthly migraine days.
Those data will give clues as to whether erenumab has an edge over other drugs aimed at calcitonin gene-related peptide, such as Lilly’s galcanezumab, Teva’s TEV-48125 and Alder Biopharmaceuticals’ ($ALDR) ALD-403. Even if Amgen is unable to identify an efficacy edge, it could still secure the advantage of being first to market. The Big Biotech has previously said it wants to parcel up the Phase II data and the readout from a Phase III trial in patients with episodic migraines into a single filing, an approach that would position it to win approval before its rivals.
Amgen reconfirmed the strategy following the Phase II release. “We believe that together with the Phase III episodic data that we expect in H2, the data could potentially support both chronic and episodic indications being granted, at least by some of the global regulators," Amgen spokesperson Kristen Davis told CNBC.
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