The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.
The approval will prevent a product shortage by allowing the sole manufacturer of the drug, QOL Medical, to obtain Sucraid's active ingredient from a different manufacturer.
Sucraid provides drug replacement therapy for patients that have been diagnosed with a congenital (inherited) disease called Congenital Sucrase-Isomaltase Deficiency (CSID). Worldwide, approximately 400 CSID patients have been prescribed Sucraid, 140 in the United States alone. Patients who suffer from CSID lack the necessary enzyme sucrase located in their gut that is required to digest sucrose (table sugar) which is in many foods. A lack of this enzyme causes diarrhea, abdominal pain and severe cramping when eating these products. Sucraid enables them to digest sucrose containing foods more readily.
To avoid interruptions in treatment, on Oct. 24, 2008, the agency authorized QOL Medical to provide the newly manufactured product to patients prior to the FDA's final action on the manufacturing supplement. The FDA also has taken new steps to protect the patients who use this treatment. The agency is requesting the company implement measures designed to evaluate the risks of adverse events associated with the new supply of Sucraid.
"The FDA has expedited its approval of the newly manufactured Sucraid," said Julie Beitz, M.D., director, Office of Drug Evaluation III, the FDA's Center for Drug Evaluation and Research. "However the manufacturing changes could lead to more frequent allergic reactions. To continue our rigorous oversight, FDA is requiring the manufacturer to inform prescribers and patients of the changes, and conduct a postmarketing study."
Sucraid, was originally approved by the FDA as an orphan drug on April 9, 1998. CSID is found amongst Alaska Natives and people from Nordic populations. Some patients are as young as 5 months old.