Lilly's Emgality Becomes First FDA-Approved Treatment for Cluster Headache, Gaining Competitive Edge in CGRP Market

Compiled by: Fan Dongdong

This Tuesday, the U.S. FDA announced approval of Eli Lilly’s Emgality for the treatment of cluster headaches, marking the second indication for Emgality following its approval for migraines and making it the first drug approved for the treatment of cluster headaches.

In September 2018, the FDA approved Eli Lilly’s Emgality injection (120 mg dose) for the preventive treatment of migraine in adults, making Emgality the third CGRP-targeted migraine therapy to reach the market, following Novartis and Amgen’s Aimovig and Teva’s Ajovy.

In terms of administration, both Aimovig and Emgality are administered via subcutaneous injection once monthly, whereas Ajovy can be administered via subcutaneous injection either once monthly or once every three months. In comparison, Emgality offers greater convenience in administration, providing patients with a differentiated treatment option. This medication is a self-administered subcutaneous injection given once monthly.

However, since its launch, Emgality’s early sales performance has lagged behind that of other CGRP competitors. In the first quarter of 2019, Aimovig generated $59 million in sales, Ajovy $20 million, and Emgality $14 million. Now, as the only FDA-approved medication for the treatment of cluster headaches, Emgality may see a boost in future sales.

Eric Pearlman, Senior Medical Director of Neuroscience at Eli Lilly, stated in an interview that the company is delighted with the FDA’s approval, as patients with cluster headaches have an urgent need for new treatments and have long been underserved. Cluster headache is the most common trigeminal autonomic cephalalgia, a severely painful primary headache disorder characterized by lacrimation, swelling, and redness. Furthermore, these patients are often misdiagnosed, leading to unnecessary ophthalmic surgeries, sinus surgeries, or tooth extractions.

Pearlman stated that patients with cluster headaches often become agitated due to the severe pain, with some even resorting to self-harm. Pearlman remarked, “The focus of this FDA approval is not merely on Emgality’s second indication, but more importantly, on the fact that 250,000 patients in the United States now finally have access to an innovative therapeutic option.” Emgality is a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP), a receptor that plays a key role in the pathogenesis of migraine. CGRP is a neuropeptide that has been shown to be released during migraine attacks and is considered a trigger for such episodes. Currently, the CGRP receptor has become a prominent target in the development of migraine medications.

As Libby Driscoll, Vice President of Neuroscience at Eli Lilly, stated, cluster headaches are “distinctly different” from migraines. Migraine is a common chronic neurovascular disorder characterized by recurrent episodes of severe headache, typically occurring on one side of the head. In contrast, cluster headaches often manifest as unpredictable, sudden attacks, commonly localized around the orbit and accompanied by symptoms such as orbital redness and swelling, ptosis, lacrimation, and nasal congestion. These episodes typically last from 15 minutes to approximately 3 hours, frequently occur at fixed times each day, and can persist for weeks to months.

Therefore, the dosage of Emgality for the treatment of cluster headaches differs from that for migraines. For migraines, the drug is primarily used as preventive therapy and is administered continuously; however, for cluster headaches, patients only need to take the medication during the active period: a 300 mg loading dose is administered at the onset of the cluster period, followed by monthly subcutaneous injections until the end of the episode. It is worth noting that each cluster period can last for several months.

Trial results showed that Emgality significantly reduces the frequency of pain attacks during cluster periods. As part of Eli Lilly’s overall pain portfolio, Emgality is the first of three investigational drugs in development. The portfolio also includes lasmiditan, developed in collaboration with Pfizer for the acute treatment of migraine in adults, and tanezumab, for the treatment of osteoarthritis pain, chronic low back pain, and cancer pain in adults.

Teva’s Ajovy previously attempted to challenge the efficacy of Emgality in cluster headache, but it now appears unlikely to pose a significant threat to Emgality. Following early Phase 3 trial analyses indicating that Ajovy was unlikely to meet its primary endpoint, Teva announced the cancellation of its research program for cluster headache.

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Lilly's scored its cluster headache nod for Emgality. Will it shake up the CGRP race?