Results

Eli Lilly posts promising PhIII migraine results, but settles into the pack in the last leg of the race to the FDA

Eli Lilly $LLY is lining up its application for its CGRP migraine drug galcanezumab after racking up a slate of date from three Phase III studies that puts it right alongside its many rivals. The headline success was heralded weeks ago, with the details unveiled Saturday at the American Headache Society annual scientific meeting in Boston.

David Ricks

CGRP drugs look like a safe way to lower the number of migraine days per month among patients with episodic and chronic migraine, the 120 mg and 240 mg doses of galcanezumab cut the average number of debilitating episodes by 4 and 3.8 days in one study for episodic migraine and 3.7 days and 3.6 days in another — compared to a placebo response that ran from 1.85 to 2.15 days.

In the Phase III for chronic migraine the 240 mg dose cut the rate of migraine days by 2.1 days over a placebo.

What’s emerging from the battery of late-stage data is a remarkably similar set of results for drugs that target CGRP. With the standard caveat that cross-trial comparisons can be inherently unreliable, based on a differing set of patient profiles and endpoints, Lilly nevertheless will be lining up alongside the leaders, Amgen/Novartis {$AMGN, $NVS}, as well as Teva $TEVA , which earlier this week reported the second set of its promising Phase III results fremanezumab (TEV-48125) that is also headed to regulators.

Little Alder $ALDR is also planning to wage a commercial war with their drug. And Allergan $AGN has a late-stage program underway for an oral CGRP therapy it in-licensed from Merck in 2015 with a $250 million upfront.

One conclusion from all this data seems inescapable. The standard for treating migraine should change for the better. Who actually comes out on top, able to differentiate themselves from the mainstream with the right dose, treatment regimen and retail price for payers, has yet to be determined. But it will be a major league matchup, with at least one David (Alder) among the Goliaths.

Analysts have been puzzling out the late-stage rivalry for months now, with little consensus on how this will all shake out. For Lilly, it’s relatively good news, especially after the debacle at the FDA with the recent, unexplained rejection of baricitinib.


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