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Jaguar Health Submits Orphan Drug Designation Application to FDA for Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Patients with Breast Cancer with Metastasis Identified by FDA as a Distinct Condition
Potential treatment for patients with breast cancer with metastasis to the brain with crofelemer would augment the significant responder analysis results for crofelemer in the prespecified subgroup of patients with breast cancer from the OnTarget ...
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Potential treatment for patients with breast cancer with metastasis to the brain with crofelemer would augment the significant responder analysis results for crofelemer in the prespecified subgroup of patients with breast cancer from the OnTarget study that were reported at the Multinational Association of Supportive Care in Cancer 2025 Annual Meeting and the 2024 San Antonio Breast Cancer Symposium","length":402,"tagName":"p"},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / September 24, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has submitted an orphan drug designation (ODD) application to the U.S. Food and Drug Administration (FDA) for crofelemer, the company's novel prescription drug, for the treatment of diarrhea in adult patients with breast cancer that has metastasized to the brain receiving targeted therapy with or without standard chemotherapy.","length":490,"tagName":"p"},{"type":"text","content":"Within the last ten years, the FDA's Office of Orphan Products Development (OOPD) has publicly acknowledged that brain metastasis of any cancer is considered a disease or condition separate and distinct from the primary site of origin. Accordingly, between 2015 and 2024 the OOPD awarded seven orphan drug designations for various therapies for the treatment of breast cancer that has metastasized to the brain.","length":415,"tagName":"p"},{"type":"text","content":""The FDA has identified the condition of breast cancer that has metastasized to the brain as an orphan indication. We have submitted this ODD application for crofelemer to treat diarrhea in these patients," said Lisa Conte, Jaguar's founder, president, and CEO. "Diarrhea is a common side effect of numerous targeted cancer therapies that can lead to dose changes, treatment delays, or cessation of treatment altogether, all of which impact patient outcomes. Given crofelemer's novel and physiological mechanism of action, we would plan to seek Breakthrough Therapy designation and/or Fast Track designation from the FDA to support potentially expedited regulatory pathways in the U.S. for crofelemer for this indication."","length":750,"tagName":"p"},{"type":"text","content":"In both the US and European Union, crofelemer has previously received orphan drug designa...