FDA Advisory Committee Recommends Datscan™ (Ioflupane I 123 Injection)

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 20 Aug 2009 - 14:00 PDT

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GE Healthcare announced that the Peripheral and Central Nervous System Drugs advisory committee of the U.S. Food and Drug Administration (FDA) has voted to recommend DaTSCAN™ (Ioflupane I 123 Injection) to the FDA. The panel determined DaTSCAN has a favorable risk to benefit profile, voting 11 to two with one abstention.

The proposed indication for DaTSCAN is for the visualization of the dopamine transporter (DaT) distribution within the striata by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration.

In May 2009, the FDA accepted the New Drug Application and granted DaTSCAN priority review, a designation identified for areas of unmet medical need. If approved, DaTSCAN will be the first radiopharmaceutical agent available to detect DaT distribution within the brain.

"We are pleased that the committee has recognized the potential benefit of DaTSCAN," said Don Black, MD, head of R&D for GE Healthcare Medical Diagnostics. "Making DaTSCAN available in the U.S. would be an important milestone for GE Healthcare and improved patient care."

The Prescription Drug User Fee Act (PDUFA) date for DaTSCAN is September 9, 2009.

About DaTSCAN

DaTSCAN has been available in Europe since 2000 and has been used in more than 200,000 patients

Source
GE Healthcare

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