January 13, 2021
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FDA grants orphan drug designation to Gleolan for use in meningioma resection

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The FDA granted orphan drug designation to aminolevulinic acid hydrochloride, an optical imaging agent that helps visualize tumor tissue during resection of meningioma, according to a manufacturer-issued press release.

Aminolevulinic acid hydrochloride (Gleolan, NX Development Corp.) is FDA approved for visualization of malignant tumor tissue of patients with glioma.

Stereotactic brain biopsy smear cytology of a meningioma, a benign brain tumor of the meninges, showing fascicles of spindle cells with psammoma bodies.
Source: Adobe Stock.

Meningioma accounts for 36% of all primary brain tumors, affecting the membranes around the brain and spinal cord. Patients with meningioma often undergo surgical debulking to help manage this disease.

A multicenter phase 3 study of aminolevulinic acid hydrochloride is currently enrolling 100 patients with newly diagnosed or recurrent meningioma and is expected to be completed in 15 months.

“We were thrilled to receive orphan drug designation to support our efforts in evaluating the potential utility of fluorescence-guided surgery in the meningioma patient population.” Alan M. Ezrin, PhD, co-founder and CEO of NX Development Corp, said in the release. “To date, the use of Gleolan in patients with suspected high-grade gliomas has been performed in excess of 80,000 patients worldwide, and the expansion into meningioma is a key initiative of our company’s worldwide strategy as we strive to develop surgical application in a variety of tumor types.”

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.