New migraine preventive Emgality cleared in general hospital

DC at SNUH, Severance, Kangbuk Samsung and GH cleared Emgality

Demonstrated prevention of migraine by once-month, 1 out 7 reached RR of 100%

Korean general hospitals are swiftly implementing a new migraine preventive medication, Emgality, on their prescription drug code.

 

According to a pharmaceutical industry insider, migraine-preventing calcitonin gene-related peptide (CGRP) antagonist Emgality (galcanezumab) has been launched last December.

 

And it has been passed by Drug Committees in Seoul National University Hospital, Severance Hospital, Kangbuk Samsung Hospital, Hallym University Dongtan Sacred Heart Hospital, and Nowon Eulji Medical Center.

 

The drug is a humanized monoclonal antibody that binds to CGRP, causing migraine symptoms in brain, and blocks its binding to the receptor.

 

The Korean government has approved the new drug has been as the first in its class.

 

Designated as an orphan drug in last April, the drug has been approved to market in last September.

 

Recently, the U.S.

 

Food and Drug Administration (FDA) has additionally indicated the drug as a treatment for episodic cluster headache.

 

Emgality’s approval was based on six-month long EVOLVE-1 and EVOLVE-2 trials with 1,773 patients with episodic migraine headache (monthly average four to 14 migraine headache days (MHD)), and three-month long REGAIN trial with 1,113 patients with chronic migraine headache (monthly average 15 headache days, more than eight MHD).

 

The two trials treating patients with episodic migraine headache for six months compared mean changes of monthly average migraine headache days from baseline (9.2 MHD in Emgality group, 9.1 MHD in placebo group) and demonstrated improved treatment effect of the drug than the placebo.

 

For six months time in the EVOLVE-2 trial, particularly with Korean participants, 226 patients in Emgality group has reduced monthly average MHD by 4.3 days, or two days more than placebo group (450 patients) that reduced MHD by 2.3 days.

 

Among the Emgality-treated group, 59 percent of the patients had 50 percent less MHD, 34 percent of them had over 75 percent less MHD, and 12 percent of them had 100 percent less MHD.

 

Whereas, 36 percent, 18 percent and 6 percent of placebo-treated group had 50 percent, more than 75 percent and 100 percent less MHD, respectively.

 

Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “Migraine headache could unimaginably damage patient’s quality of life.

 

Patients with average four to five MHD in a month could expect to improve their quality of life with preventive treatment.

 

While anti-hypertension and anti-epileptic medications were recommended for migraine preventive treatment, Emgality’s launch is a hopeful news to the patients.” Meanwhile, a series of CGRP-class medications have been released throughout last year.

 

Besides Emgality, Aimovig (erenumab) co-developed by Novartis and Amgen and Ajovy (fremanezumab) by Teva have entered the market.