Lilly Receives FDA Priority Review for Emgality (galcanezumab-gnlm) as Preventive Treatment for Episodic Cluster Headache in Adults

March 6, 2019/BioValleyBIOON/--Pharmaceutical GiantEli Lilly(Eli Lilly) recently announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation to its supplemental Biologics License Application (sBLA) for Emgality (galcanezumab-gnlm), a new migraine medication, for the preventive treatment of episodic cluster headache (ECH) in adults. Priority Review isFDAa new drug approval pathway designed to expedite the review of drug applications, which, if approved, may represent a significant advance in the treatment of serious diseases.

This sBLA is based on data from a Phase III clinical study conducted in 106 adult patients with ECH, which evaluated the efficacy and safety of Emgality. Previously,FDABreakthrough Therapy designation for Emgality in the preventive treatment of ECH was granted in September 2018.

Cluster headache (CH) is a primary headache disorder classified as a trigeminal autonomic cephalalgia. Episodic cluster headache (ECH) accounts for 85% to 90% of CH cases. This disabling condition has a prevalence of approximately 124 cases per 100,000 adults. Currently, insufficient awareness of CH leads to frequent misdiagnosis. In the United States, there are no approved medications for the preventive treatment of ECH.

Eli LillyGudarz Davar, Vice President of Neurology Development at the biopharmaceutical company, stated, “Cluster headache is a severely disabling and painful neurological disorder with few treatment options, only some strictlyClinical Triallimited research. We are pleasedFDA“Priority review was granted for our sBLA, acknowledging the need for new treatments for this debilitating disease and bringing us closer to providing a preventive treatment option for these patients.”

Emgality selectively blocks the calcitonin gene-related peptide (CGRP) receptor, which 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 migraine episodes. Currently, the CGRP receptor has become a prominent target in the development of migraine medications.

In the United States, Emgality was approved in September 2018FDAApproved for the prevention of migraine in adults. Migraine is a neurological disorder characterized by recurrent episodes of severe headache. More than 30 million adults in the United States suffer from migraine. Currently,Eli LillyPatients are being recruited for a Phase III clinical study to evaluate the efficacy of Emgality in preventing migraine in children and adolescents (aged 6 to 17 years).

AsEli LillyAs part of the overall pain portfolio, Emgality is the first of three investigational drugs under development. The portfolio also includesPfizerLasmiditan, co-developed 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.

In mid-November last year,Eli LillyA New Drug Application (NDA) for lasmiditan has been submitted to the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adult patients. Lasmiditan is an investigational, orally administered, centrally penetrating, selective serotonin 1F (5-HT1F) receptor agonist. It differs structurally and mechanistically from currently approved migraine medications and lacks vasoconstrictive activity. Notably, lasmiditan is the first and only molecule in the “ditan” class evaluated for the acute treatment of migraine in adults. If approved, it would represent the first major innovation in migraine therapy in more than two decades. (Bioon.com)

Original Source:Lilly Receives FDA Priority Review Designation for Emgality? (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults