Lilly releases first non-reimbursed 'Emgality'

Prophylactic efficacy demonstrated once a month, 1 in 7 patients achieved 100% response rate

Eli Lilly's migraine new drug 'Emgality' was released in Korea.

 

Lilly Korea announced on the 12th that it will release non-reimbursed CGRP-targeted migraines prevention drug, Emgality (Galcanezumab).

 

This drug is a humanized monoclonal antibody that binds to the Calcitonin gene-related peptide (CGRP) molecule which plays a key role in causing migraine symptoms in the brain and blocks binding to receptors.

 

.This is the first drug in Korea

 

.Last year, after being approved for migraine treatment, it recently acquired additional FDA approval for episodic cluster headache treatment

 

.The permission was granted for the EVOLVE-1 and EVOLVE-2 studies in which 1,773 people with migraine headaches (average migraine days 4-14 days per month) participated for 6 months, and chronic migraine patients (average headache days 15 days, migraine days 8 months or more)

 

.The study was based on a REGAIN study involving 1113 people over 3 months

 

.Through two clinical trials for episodic migraine patients, placebo of Emgality-treated patients for migraine treatment compared to baseline (9.2 days for Emgality group, 9.1 days for placebo group) across six months of clinic compared to average monthly migraine incidence for 6 months

 

.Therapeutic benefit was proved

 

.In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of migraine headaches for 6 months in the Emgality group (226 patients) was reduced by 2 days (4.3 days in the Emgality group, 2.3 days in the placebo group) compared to the placebo group (450 patients)

 

.Amgelity-treated patients who had 50% reduction in the number of days of migraine headaches over 6 months were 59% (36% placebo), 75% reduction were 34% (18% in the placebo group), and 100% reduction were 12% (6% in the placebo group)

 

.Min-kyung Chu, neurology professor of Severance hospital, said “Migraine is a pain beyond our imagination that impairs the quality of life of patients, Patients who experience migraines more than four to five days a month can expect to improve their quality of life through preventive care

 

.Emgality's launch is encouraging, with high blood pressure and epilepsy drugs being recommended for preventive treatment

 

.Until now, high blood pressure medications and epilepsy medications have been recommended for preventive treatment”

 

.Meanwhile, commercialization of CGRP-based therapeutics has been ongoing since last year

 

.In addition to Emgality in the United States, drugs such as Aimovig (Erenumab) and Teva's Ajovy (Fremanezumab), which have been jointly developed by Novartis and Amgen, have entered the market.