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光線力学診断用剤「アラグリオ顆粒剤分包 1.5g」「アラグリオ内用剤1.5g」 の用法変更に関する一部変更承認取得のお知らせ

Notice of partial approval for changes in the usage of diagnostic agents for optical ray mechanics, 'Alaglio granules 1.5g' and 'Alaglio oral agent 1.5g'.

SBI Holdings ·  Sep 23 23:00

September 24, 2024
SBI Pharma Co., Ltd.

SBI Pharma Co., Ltd., a subsidiary of SBI Holdings, Inc., conducts research and development of pharmaceuticals that utilize 5-Aminolevulinic Acid (5-ALA) (※). The company, located in Minato-ku, Tokyo, with President and CEO Yoshitaka Kitao, has obtained approval for partial changes in manufacturing and marketing approval regarding the change in usage of 'Alaglio Granules 1.5g' and 'Alaglio Oral Solution 1.5g' (hereinafter referred to as 'Alaglio'), distributed by Nippon Kayaku Co., Ltd., and wishes to make this announcement.

Based on the results of domestic Phase III clinical trial (SPP2C102 trial: jRCT2061210055), an application for partial changes in manufacturing and marketing approval was submitted in January 2024 and has been approved.
As a result, the current usage (administer orally by dissolving in water 3 hours before cystoscopy [range: 2 to 4 hours before]) has been changed to 'administer orally by dissolving in water 2 to 8 hours before cystoscopy.' This change allows for a more flexible timing of Alaglio administration before surgery, improving convenience.

We will continue to dedicate ourselves to research and development to contribute to the health and well-being of everyone. We strive to further enhance the beneficial use of Alaglio by more patients and healthcare professionals who are addressing bladder cancer, aiming to help visualize cancer and develop it as an intraoperative diagnostic drug.

(※) 5-Aminolevulinic Acid is one of the amino acids produced in the mitochondria of the body. When taken up by cancer cells, it accumulates the main metabolic product, Protoporphyrin IX. By utilizing the property where Protoporphyrin IX emits fluorescence when exposed to excitation light, it has been practically used as a diagnostic agent for cancer visualization, making further advancements in its development.

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