Pharmaceutical giant and Company Eli Lilly Recently announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental Biologics License Application (sBLA) for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache (ECH) in adults. The sBLA was based on data from a phase III clinical study conducted in 106 adult patients with ECH to evaluate the efficacy and safety of Emgality. Previously, the FDA had granted Emgality the breakthrough therapy designation (BTD) for preventive treatment of ECH in September 2018.
Cluster headache (CH) is a primary headache called trigeminal autonomic headache. Episodic cluster headache (ECH) accounts for 85% to 90% of CH cases, which is a disabling disease with a prevalence rate of about 124 per 100,000 adults. At present, the lack of understanding of CH leads to misdiagnosis. In the United States, there is no approved drug for the preventive treatment of ECH.
Gudarz Davar, vice president of neuroscience development in Lilly, said, “Cluster headache is a severely disabled and painful neurological disease with few treatment options and only limited research in rigorous clinical trials. We are pleased that FDA has granted priority review to our sBLA, which recognizes that this devastating disease requires new treatment and brings us closer to providing these patients with a preventive treatment option. ”
Emgality specifically blocks calcitonin gene-related peptide (CGRP) receptor, which plays a key role in the occurrence of migraine. CGRP is a neuropeptide that has been shown to be released during migraine attacks and is considered to be the cause of migraine attacks. At present, CGRP receptor has become a hot target for migraine drug research and development.
In the United States, Emgality was approved by the FDA in September 2018 to prevent migraines in adults. Migraine is a neurological disease characterized by recurrent severe headaches. More than 30 million of American adults suffer from migraines. Currently, Lilly is recruiting patients for phase III clinical studies to evaluate the effectiveness of Emgality in the prevention of migraine in children and adolescents (6 to 17 years age). As part of Lilly’s overall pain mix, Emgality is the first of three experimental drugs under development. The portfolio also includes lasmiditan, developed in collaboration with Pfizer for acute treatment of migraine in adults, and tanezumab, for the treatment of osteoarthritis pain, chronic low back pain and cancer pain in adults.
In mid-November last year, Lilly submitted a new drug application for lasmiditan to the United States for acute treatment of migraines in adults with or without aura symptoms. The drug is an experimental, oral, central nervous system permeability, selectivity, serotonin 1 F (5-HT1F) agonist. It is different in structure and mechanism from the currently approved migraine drugs, and there is no vasoconstrictive activity. It is worth mentioning that lasmiditan is the first and only drug molecule in the “-ditan” class to be evaluated for acute treatment of migraine in adults. If approved, the drug would represent the first major innovation in migraine treatment in more than 20 years.