This article is more than 5 years old. Information may no longer be current.
FDA grants orphan drug designation to marizomib for malignant glioma
Click Here to Manage Email Alerts
The FDA granted orphan drug designation to marizomib for the treatment of patients with malignant glioma, according to a press release from the drug’s manufacturer.
Marizomib (Triphase Accelerator Corporation) — a brain-penetrant proteasome inhibitor — is being evaluated in combination with bevacizumab (Avastin, Genentech) for treatment of patients with recurrent glioblastoma.
“The orphan drug designation granted by the FDA recognizes the unique potential of marizomib to benefit patients with malignant glioma, for whom current therapies provide minimal benefit,” Mohit Trikha, PhD, chief scientific officer of Triphase Accelerator, said in the press release. “Our Triphase Accelerator model enables faster and more efficient drug development than traditional approaches due to our extensive clinical and regulatory experience in developing marizomib, and our relationships with key investigators and leading institutions.”
The FDA’s 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.