Lilly aims to leapfrog rivals with cluster headache approval

There were three approvals for treatments inhibiting the calcitonin gene-related peptide (CGRP), with Amgen-Novartis’ first-in-class Aimovig​ (erenumab), Teva’s Ajovy​ (fremanezumab), and Eli Lilly’s Emgality​ (galcanezumab) all entering the market during the same.

However, Lilly’s treatment has set itself apart from its rival treatments after receiving the first US Food and Drug Administration (FDA) approval for the treatment of episodic cluster headaches in adults.

Initial approvals for the raft of CGRP treatments were for the preventative treatment of migraines, with cluster headaches differing from this indication due to the nature of the condition that features abrupt onset of severe pain on one side of the head, often around the eyes or temples.

“Episodic cluster headache can be devastating. The approval of Emgality for the treatment of episodic cluster headache is an important milestone as it provides a new treatment option, which has been long-awaited by those impacted by this disease,”​ said Christi Shaw, president of Lilly Bio-Medicines.

Emgality is administered as three consecutive subcutaneous injections at the onset of a cluster period and then monthly until the period is over.

In clinical trials, 71.4% of patients had their weekly cluster headache attacks reduced by half from baseline against 52.6% of patients treatment with a placebo.

The treatment will be priced at the same level as its previous indication, for the treatment of migraines, at a $575 (€495) monthly and $6,900 annual cost.

Sales of the product reached $14.2m in the first quarter of 2019, which is comparatively lower than rival treatments Aimovig ($59m) and Ajovy ($20m).

However, the treatment was the last to reach market and its new indication could see sales rise due to a greater potential patient population. Lilly estimates that there are approximately 250,000 adults living with the condition in the US alone.