Lilly firms up case for Emgality in migraine market chase

Eli Lilly’s third-to-market migraine prevention drug Emgality has a lot of ground to make up on its rivals, but a new study in people who have failed earlier migraine therapies could help.

The company says that CGRP inhibitor Emgality (galcanezumab) hit all its objectives in the phase 3 CONQUER trial, which involved chronic and episodic migraine patients who had failed two to four different migraine prevention drugs.

At enrolment, patients in the study had an average of 13.2 days in the month when they were experiencing headaches. Treatment with Emgality reduced that total by 4.1 days, versus a cut of just one day with placebo.

Preventive treatment failure is a big problem in migraine, according to Lilly, but an estimated 40% of patients don’t try to switch treatments even though they are not getting adequate protection against attacks.

Emgality was approved for marketing last September, reaching the market several months after two other CGRP inhibitors – Amgen/Novartis’ Aimovig (erenumab) and Teva’s Ajovy (fremanezumab) – and setting up a three-way marketing battle.

Amgen reported sales of $83 million for first-to-market Aimovig in the second quarter, while Lilly said its drug made $34m. Teva isn’t due to report its second-quarter results until tomorrow, but booked $20m from Ajovy in the first three months of the year.

Showing efficacy in treatment failures helps round out Emgality’s clinical profile, and might encourage prescribers to offer it as a switch therapy for migraineurs struggling to control their headaches with other drugs.

It’s not the only weapon in Lilly’s arsenal, however, as in June it picked up an FDA approval for Emgality in episodic cluster headache in adults. Ajovy failed a phase 3 trial in cluster headache prevention, while Amgen and Novartis don’t seem to be testing Aimovig in cluster headache, so that gives Lilly another differentiator for its drug, albeit in a smaller patient population than migraine.

In its second-quarter results, Lilly said that its drug exited the three-month period with a 41% share of the market for new-to-brand prescription in the US, up 9 points from the end of the first quarter of the year.

“We look forward to Emgality continuing its strong uptake in the US, and contributing meaningfully to sales in the second half of 2019,” said the company’s chief financial officer Josh Smiley.