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# Paradigm Plans NDA for Rare Skin Disorder
- URL: https://www.fdaweb.com/paradigm-plans-nda-for-rare-skin-disorder/
- Published: 2025-05-09T12:00:00.000Z
- Updated: 2026-09-14T15:11:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159156

Paradigm Therapeutics plans to file an NDA in the second half of this year for Zorblisa (SD-101), as a topical whole-body treatment for all subtypes of epidermolysis bullosa (EB) patients. “Epidermolysis Bullosa is a devastating disease,” the company says. “Results from the completed Phase 2 and Phase 3 trials indicate that SD-101 demonstrated a broad benefit with whole body treatment of the lesions and wounds on the entire skin surface in pediatric and adult patients across all EB patients, who have limited whole body treatment alternatives.”

The rare genetic disorder causes very fragile skin that leads to severe skin blistering and open wounds often beginning at birth, the company says. Zorblisa is a topical cream that has demonstrated the potential to provide improvement in treating the severe skin disruptions seen in EB patients, it adds.