Koselugo is about to be approved in Korea

Approved by the US FDA last year

Koselugo (Selumetinib) is the FIRST and ONLY FDA-approved prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery.

 

It is not known if Koselugo is safe and effective in children under 2 years of age.

 

And, it is about to be approved in Korea.

 

The FDS last year supported the drug by designating it as an "Expanded Review target for Expedited Review".

 

According to industries on the 7th, the MFDS recently completed a safety and validity examination of AstraZeneca's Koselugo.

 

Koselugo is a new drug used in the treatment of type 1 neurofibromatosis, which is inoperable in children over the age of three.

 

In October last year, the MFDS designated the drug as an Expedited Review target, saying that it is life-threatening and constitutes a serious disease treatment.

 

"If designated as an Expedited Review target, we can receive a Priority Review compared to other medicines.

 

The screening period will be shortened to up to 90 days.

 

Koselugo was quickly reviewed by the FDA and approved in April last year after six months.

 

Neurofibromatosis Type I is a genetic nervous system disorder in which tumors proliferate in the nerve region, showing the characteristics of tumors destroying normal cells such as faces.

 

Therefore, it causes skin discoloration, damage to the nervous and skeletal system, and risk of developing benign and malignant tumors.

 

There has been no fundamental treatment method, so symptomatic treatments such as medication and lesion resection have been carried out depending on symptoms.

 

Koselugo's release is expected to make patient care much easier.

 

Clinical trials used Koselugo every 28 days to compare tumor size changes and tumor-related mortality.

 

As a result, the objective response rate (ORR) of the Koselugo treatment group was 66%, and patients with 82% ORR continued to respond for more than 12 months.

 

As the MFDS' review has been completed, it is expected to be approved as soon as possible unless there are other supplements.