Jaguar Health Seeks Orphan Drug Designation for Crofelemer

Jaguar Health, through Napo Pharmaceuticals, has applied for orphan drug designation (ODD) from the FDA for crofelemer. This application targets diarrhea treatment in breast cancer patients with brain metastasis undergoing targeted therapy, with or without standard chemotherapy. This condition is recognized by the FDA as distinct, underscoring the importance of this submission.

Crofelemer had previously secured orphan designation for other conditions in the US and EU. Jaguar Health aims to expedite the drug's regulatory process, exploring Breakthrough Therapy or Fast Track designations. The significance of this effort lies in addressing a common side effect that can disrupt cancer treatment and impact patient outcomes.