FDA grants orphan drug designation to iniparib for glioma
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The FDA granted orphan drug designation to iniparib for treatment of malignant glioma, according to the agent’s manufacturer.
Iniparib (TriAct Therapeutics) is designed to kill cancer cells by targeting their redox metabolism, spiking oxidative stress levels and triggering programmed cell death, according to a TriAct-issued press release.
A phase 2 study that included patients with newly diagnosed glioblastoma met its primary survival and safety endpoints. The company now is designing a trial intended to support submission of a new drug application to regulatory authorities in the United States and Europe.
“Receiving orphan drug designation is an important milestone in our effort to bring this promising new therapy to both adult and pediatric patients suffering from malignant gliomas, including newly diagnosed glioblastoma,” Tom White, co-founder and CEO of TriAct, said in the release. “With a 3-year survival rate of 16% for [patients with newly diagnosed glioblastoma], this designation is also an acknowledgement of the urgent need to intelligently but expeditiously develop promising new therapies for these patients. Consequently, following FDA guidance from our end-of-phase 2 meeting earlier this year, we are also filing for fast track designation.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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