The Senior Medical Director at Eli Lilly discussed the clinical impact galcanezumab could have for patients with cluster headache if approved by the FDA.
Jim Martinez, MD
The FDA recently granted Eli Lilly and Company’s galcanezumab (Emgality) breakthrough therapy designation for episodic cluster headache and intends to file a supplemental biologics license application by the end of the year.
A phase 3 trial, one of the first placebo-controlled studies performed in cluster headache, showed that across weeks 1 to 3 of the 2-month study period, monthly injections of 300-mg galcanezumab led to a statistically significant reduction in the frequency of cluster headache attacks compared to placebo (-8.7 reduction for galcanezumab versus -5.2 reduction for placebo; P = .036). It was also reported that in regard to the secondary endpoint, a statistically significant greater percentage of patients in the intervention arm (76%) achieved ≥50% reduction in weekly cluster headache attacks compared to placebo (57%) (P = .04) at week 3.
To provide additional insight into how galcanezumab could change the treatment landscape of cluster headache, NeurologyLive spoke with Jim Martinez, MD, Senior Medical Director, Eli Lilly and Company, in an interview.
Jim Martinez, MD: Episodic cluster headache is a severely painful headache disorder that can have a devastating impact on a person’s life. In part because episodic cluster headache can be difficult to study in clinical trials, there are few treatment options. In the U.S., there are currently no approved preventive treatments for episodic cluster headache. If approved, galcanezumab (Emgality) could provide a potential new treatment option for people living with episodic cluster headache, many of whom may have felt ignored and alone in their struggle.
Lilly has spent the last 25 years researching innovative therapies to treat headache disorders, and we are thrilled to be one step closer to potentially providing a new option for the preventive treatment of episodic cluster headache.
The main purpose of this trial is to assess the long-term safety and tolerability of galcanezumab in patients with episodic or chronic cluster headache. Patients that participated in and completed previous episodic or chronic cluster headache studies with galcanezumab were potentially eligible to enroll. The study is evaluating 300 mg of galcanezumab administered subcutaneously up to once monthly.
This long-term safety study will provide additional information about the safety and tolerability of galcanezumab in patients with cluster headache. The CGAM (NCT02438826) and CGAL (NCT02397473) phase 3 clinical trials, which evaluated a combined 343 patients, are the largest controlled preventive trials conducted in cluster headache to date. Galcanezumab, if approved, will be the first preventive option approved for patients with episodic cluster headache in the United States.
Galcanezumab was approved in September 2018 for the preventive treatment of migraine in adults, and Lilly recently announced plans to submit a supplemental Biologics License Application (sBLA) to the FDA for galcanezumab for the preventive treatment of episodic cluster headache in adults by the end of the year. Lilly is also recruiting patients ages 6 to 17 years of age for a phase 3 study of galcanezumab for the preventive treatment of episodic migraine in children and adolescents. A study in children and adolescents with chronic migraine is also planned.
Transcript edited for clarity.