2nd anti-CGRP migraine drug Ajovy seeks approval in Korea

Handok Teva expects to receive approval by June and to compete against Emgality

Reimbursement standard to remain limited, but non-reimbursed use would be as popular

A second anti-calcitonin gene-related peptide (CGRP) treatment for migraine is preparing for the Korean market.

 

According to pharmaceutical industry sources, Handok Teva has submitted approval application on CGRP targeted migraine treatment Ajovy (fremanezumab) aiming for the Ministry of Food and Drug Safety’s nod by late June.

 

Ajovy’s migraine prevention effect has been evaluated in two Phase 3 clinical trials on patients with unbearable migraine pain affecting their daily lives.

 

The results proved Ajovy reduces more number of days with migraine than the placebo group.

 

When it receives the Korean government’s approval, Ajovy would compete against Lilly’s Emgality (galcanezumab) in both reimbursed and non-reimbursed drug markets.

 

The two drugs are humanized monoclonal antibody (mAb) that binds to CGRP ligand playing a crucial role of causing migraine, and blocks its binding to the receptor.

 

Ajovy has improved its drug compliance by offering both monthly and quarterly injection options.

 

After winning the U.S.

 

Food and Drug Administration’s (FDA) approval in September 2018, it also gained European Commission’s (EC) approval in just six months.

 

Emgality has been released in the Korean market as non-reimbursed drug in last December.

 

As none of the drug in the class has been listed for reimbursement, the competition between two drugs over the listing would get fierce.

 

CGRP mAbs are relatively expensive drugs so the first listing standard would be limited to at least third-line treatment.

 

However, considering patients suffering from migraine have such a low quality of life and have limited treatment options, the non-reimbursed use of the drugs would be as popular as well.

 

Professor Chu Min Kyung of Neurology Department at Severance Hospital explained, “The pain from migraine is beyond imaginable and it significantly harms patients’ quality of life.

 

Patients experiencing headache more than four to five days a month could expect to improve quality of life by preventive treatment.

 

Because the condition uses hypertension and epilepsy treatments as preventive treatment at the moment, CGRP mAb would be a preferred option in the future.”