Results

Lining up against rivals, Amgen and Novartis build a blockbuster case for their CGRP migraine drug

Amgen $AMGN and its partners at Novartis $NVS rolled out a fresh batch of solidly positive data from the latest Phase III study of their CGRP migraine drug erenumab, backing up their belief that they can break past a lineup of rivals and make a blockbuster score following a near certain approval now on the horizon.

The drug, which they plan to sell as Aimovig, will likely be challenged by a group of competitors from Eli Lilly $LLY, Teva $TEVA and Alder $ALDR that have all demonstrated broadly significant data in cutting the number of migraine days experienced by a chronic sufferer. So they plan to hit the market with a battering ram of data to help clear the way with providers.

To that end, this new study demonstrated a significant response in cutting the number of migraine days for patients who had failed two to four different lines of therapy by at least 50%. Compared with a placebo, the drug also hit all the secondaries on the need for rescue meds, 75% and 100% responders, and more.

Sean Harper

I talked to Amgen R&D chief Sean Harper about this drug at JPMorgan earlier in the month, and he agreed that the drug was a near certain lock at the FDA, with a likely arrival of a slate of rivals alongside it.

“On efficacy,” he notes, “the drugs are all seeming to have similar efficacy. I think that’s fair.”

But that doesn’t mean that Amgen and Novartis, with all their considerable marketing clout, can’t make their drug the standout.

The broad late-stage program includes unique cardio data, says Harper, that should help make their case. And they were careful to come up with what they see as the best delivery option, with a simple once-monthly autoinjector that doesn’t require patients to take loading doses, which he says the competition will require.

And it’s a massive market, with some 6 to 8 million patients who fit the severe sufferer profile for the drug.

“These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig,” Harper said in a statement. “We look forward to working with regulators to bring the first preventive option specifically developed for migraine to patients worldwide.”


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