FDA grants rare disease designation to Clarity agent

By AuntMinnie.com staff writers

September 10, 2020 -- Radiopharmaceutical firm Clarity Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation (RPDD) to its radiopharmaceutical for neuroblastoma.

The agent, Cu-64 SARTATE, is designed for the clinical management of neuroblastoma in children. A clinical trial evaluating the radiopharmaceutical is currently underway at Memorial Sloan Kettering Cancer Center.

The FDA gives RPDD status to drugs and biologics designed for serious or life-threatening diseases that affect fewer than 200,000 children per year in the U.S. Neuroblastoma is the most common cancer diagnosed in children under the age of one and accounts for 15% of pediatric cancer deaths, according to Clarity.


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