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Sancilio Pharmaceuticals Company, Inc. (SPCI) Receives Rare Pediatric Disease Designation From the US Food and Drug Administration for Altemia, a Treatment of Sickle Cell Disease (SCD) in Children
Sancilio Pharmaceuticals Company, Inc. (SPCI) today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Altemia™ Soft Gelatin Capsules for the treatment of sickle cell disease (SCD) in children. Altemia™, a leading development program for SPCI, is being developed as an oral, once-a-day formulation for children between the ages of 5 – 17 with SCD.
“The FDA’s Rare Pediatric Disease designation for Altemia™, in addition to the previously granted Orphan Drug Designation, further stresses the Agency’s recognition that the SCD community faces a critical need for new treatments like Altemia™,” said Dr. Frederick Sancilio, President and Chief Executive Officer of SPCI. “We continue to make important progress in our clinical trial; a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Altemia™ in pediatric patients. We look forward to reporting top-line results from the study early in the fourth quarter, this year.”
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This platform is made possible through a partnership with the Sickle Cell Disease Association of America, Inc. (SCDAA) and its member organizations. SCDAA's mission is to advocate for people affected by sickle cell conditions and empower community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.