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FDA-Authorized Expanded Access Programs Utilizing Jaguar Health's Novel Crofelemer Powder for Oral Solution to Treat Two Pediatric Intestinal Failure Patients with Microvillus Inclusion Disease
Accessnewswireยท 2025-09-30 13:00
Core Viewpoint - Jaguar Health's subsidiary, Napo Pharmaceuticals, is providing a novel crofelemer powder for oral solution under FDA-authorized expanded access programs to treat pediatric intestinal failure patients with microvillus inclusion disease (MVID) [1] Group 1: Company Initiatives - Napo Pharmaceuticals is committed to supplying the crofelemer formulation as an investigational drug for two patients, as deemed medically necessary by their physician caregivers [1] - The initiative aims to mitigate the sequela from the progression of MVID disease [1] Group 2: Regulatory Aspects - The programs are being conducted under separate Single-Patient Investigational New Drug (sIND) applications in the United States [1] - The expanded access programs have received authorization from the U.S. Food and Drug Administration (FDA) [1]