SBI Pharmaceuticals And Nobelpharma Submit NDA In Japan For Oral Diagnostic Drug Aminolevulinic
This article was originally published in PharmAsia News
Executive Summary
SBI Pharmaceuticals and Nobelpharma announced July 6 they submitted a new drug application for an orally administered diagnostic drug used during surgery for malignant glioma.
SBI Pharmaceuticals and Nobelpharma announced July 6 they submitted a new drug application for an orally administered diagnostic drug used during surgery for malignant glioma. The active ingredient in the drug is aminolevulinic acid hydrochloride (ALA). The drug is administered two to four hours before surgery, and causes the tumor site to turn red when exposed to light. Joint clinical trials by SBI and Nobelpharma confirmed efficacy and safety when differentiating tumor sites from normal tissue. The drug is already marketed in more than 20 countries in Europe. “In addition to contributing to tumor removal rates during surgery, it is expected to reduce physical burden on patients during and after surgery,” the companies commented. The drug is based on a licensing agreement between SBI and German company Medac. (Click Here For More – Japanese Language)
“Domestic Application For Orally Administered Medicine For Malignant Glioma From SBI Pharmaceuticals and Nobelpharma” – mixonline.jp(7/10/2012)