- Teva is stopping a Phase 3 study evaluating Ajovy as a cluster headache treatment after a futility analysis showed the migraine drug is unlikely to reduce the number of attacks, the Israeli drugmaker said Tuesday.
- The trial discontinuation will expand the opportunity for Eli Lilly's Emgality to differentiate itself with a new indication in episodic cluster headaches. A Lilly spokesperson said the drugmaker expects a Food and Drug Administration decision in the second quarter for its supplemental application, which received priority review designation last month.
- These types of medicines, called CGRP inhibitors, entered the preventive migraine space last year with three launches within a few months. Teva is carrying on Ajovy development with a Phase 2 study in post-traumatic headache, while Lilly is evaluating its drug in Phase 3 studies for preventing migraines in adolescents.
Just one drug holds an FDA clearance for cluster headache, Imitrex (sumatriptan succinate), approved in the 1990s for acute treatment. If approved, Lilly's anti-CGRP drug would be the first preventive medication.
Cluster headaches cause daily attacks in patients, affecting one side of their head for a month or two before subsiding and returning months later. Each attack typically lasts anywhere from 30 minutes to three hours, and they commonly occur at night, waking people from sleep.
While this episodic variant is more common, the chronic version is more unrelenting on patients, Mark Green, director of headache and pain medicine at the Mount Sinai School of Medicine told BioPharma Dive.
"I've been doing this for 40 years, and I don't know of any doctor that has been doing headache for 40 years who doesn't have stories of someone who committed suicide with cluster who didn't respond to treatment," Green said. "It's really that terrible, particularly in chronic."
The peculiarities of cluster headaches also make it difficult to test in clinical trials.
Studies are also difficult given the cyclical nature of the disorder, Alexander Mauskop, director of the New York Headache Center, told BioPharma Dive.
"It's very hard to do these trials because very often cluster headaches just stop on their own," said Mauskop, also a professor of clinical neurology at the State University of New York Downstate Medical Center.
Both headache specialists said there is a need for better medical options and expressed hope in Lilly's Emgality (galcanezumab). A late-stage study in roughly 100 episodic cluster headache patients found the CGRP inhibitor cut the number of weekly attacks by at least half for 76% of patients, compared to 57% on placebo.
"Lilly's data is impressive," Mauskop said. "Injecting galcanezumab seems to help prevent cluster headaches, which is great because we do need some effective, preventive therapies for cluster headaches."
Green also pointed to Alder BioPharmaceuticals' eptinezumab as an option to watch, especially if it can show faster-acting effects in cluster headache through its IV administration. Alder said Monday the FDA had accepted its drug application for preventive migraine, anticipating a commercial launch in early 2020.