Koselugo is keen to discuss the registration of benefits

It was proposed by the HIRA drug benefit assessment committee

68% of clinical patients reduce tumor size

Attention is focusing on whether Koselugo, a drug-free treatment for neurofibroma, will succeed in registering insurance benefits.

 

According to related industries, AstraZeneca's new neurofibromatosis drug Koselugo is under final coordination at the Drug Benefit Standards Subcommittee.

 

AstraZeneca quickly supplemented the data in May and resumed discussions on registration at the HIRA Drug Benefit Evaluation Committee in March.

 

As it is a rare disease area where there were no treatment options, it remains to be seen whether Koselugo will be able to draw a decision this time.

 

Neurofibroma has relied on symptomatic treatment without proper treatment.

 

Neurofibroma is a rare disease in which tumors occur in nerve tissue, bones, and skin, and about 85% are type 1 in which the NF1 gene of the 17th chromosome long arm is mutated.

 

This disease begins with 1~3cm sized cafe au lait macules appearing in children.

 

It experiences symptoms such as brain tumors at the age of 6 and scoliosis at the age of 6 to 10.

 

In adults, Lisch nodule, which occurs in the iris, is mostly found.

 

It is a method of removing possible areas through surgery or chemotherapy and radiation treatment.

 

However, most of the surgeries recur, and most of them are major surgeries, so both medical staff and patients are burdened.

 

In particular, pediatric patients often have to take painkillers even after several surgeries and suffer from speech and motor disorders.

 

Koselugo is a treatment jointly developed by AstraZeneca and MSD.

 

It blocks MEK activity and inhibits cell line growth.

 

In the SPRINT phase 2 clinical trial on which the permit was based, Koselugo reduced tumor size by more than 20% in 68% of administered patients, achieving the primary evaluation index, ORR.

 

In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months.

 

Half of the patients who did not receive treatment suffered from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to three years ago.