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# FDA Orphan Status for Allena Pharma Drug
- URL: https://www.fdaweb.com/fda-orphan-status-for-allena-pharma-drug/
- Published: 2017-07-13T12:00:00.000Z
- Updated: 2026-09-14T22:34:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139131

FDA has granted Allena Pharmaceuticals an orphan drug designation for ALLN-177, an oral formulation of oxalate decarboxylase for treating primary hyperoxaluria. The rare genetic disorder is caused by endogenous overproduction of oxalate by the liver that can result in kidney stone disease, kidney damage, and kidney failure. Oxalate decarboxylase is a non-absorbed enzyme that works in the gastrointestinal (GI) tract, where it can degrade both dietary and endogenously produced oxalate, according to the company. GI elimination of oxalate may help alleviate the chronic systemic oxalate burden on primary hyperoxaluria patients, it says.