With Amgen and Novartis eagerly awaiting their PDUFA date for the leading CGRP migraine drug Aimovig later this week, Eli Lilly is stepping up with some mixed Phase III results for its own contender in the field.
In a hit and a miss, Lilly researchers say that galcanezumab scored on the primary endpoint in a Phase III study of patients suffering from episodic, weekly cluster headaches. Placed up against a placebo, their drug achieved a statistically significant reduction in cluster attacks — though the p value of 0.036 was a long way from a standout grade.
Lilly also noted that another Phase III for chronic cluster headaches failed — though you can be sure the pharma giant was far more eager to highlight the positive results in its release. And now Lilly execs are setting up talks with regulators about the way forward to the market.
Lilly has already posted its positive late-stage data for this drug in successfully reducing migraines. CGRP drugs are widely viewed as the upcoming standard of care for this category of disease, and Amgen and Novartis aim to push hard to capitalize on their frontrunner status — provided the FDA comes through as expected with an approval within a couple of days.
Analysts have offered a $1.2 billion peak sales estimate for Aimovig — making it a top-12 drug for this year — which illustrates just how important a groundbreaking position can be in drug development.
Lilly is in a familiar position further back in the field, as it awaits an FDA decision sometime in the third quarter. But they should be next in line behind the Amgen/Novartis team. Teva’s rival fremanezumab had been in line for a June decision, then earlier this month conceded that manufacturing problems would temporarily derail its program and push any approval and marketing launch further back in the year. And in March little Alder, which also has a contender in the mix, ousted its CEO and began to restructure after falling behind the leaders.
Eli Lilly has been scrambling to beef up its oncology pipeline with bolt-on deals this year. The pharma giant has gained a number of new approvals in recent years, but was seriously delayed on baricitinib last year, before the FDA abruptly decided to allow their marketing pitch to move through a review without a required safety trial.
“Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience,” said Christi Shaw, president of Lilly Bio-Medicines. “The positive results in episodic cluster headache are truly a landmark moment—both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache.”
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