Jaguar Health Discusses Crofelemer Pathway with FDA

Jaguar Health, Inc. recently met with the U.S. FDA to discuss the potential approval pathway for crofelemer, intended for cancer therapy-related diarrhea (CTD) in metastatic breast cancer patients. The company seeks to address this population, qualifying as an orphan disease group. Jaguar plans to pursue an expanded access program for patients not eligible for pivotal trials.

Napo Pharmaceuticals, part of Jaguar, presented dual pathways for crofelemer availability, emphasizing the significant unmet need among patients. Engagement with patient advocates highlighted the chronic nature of CTD due to advances in targeted cancer therapies.

While the OnTarget trial's primary goal wasn't met, significant results in a subgroup were achieved. Jaguar aims to obtain orphan drug designation, potentially facilitating faster regulatory processes through Breakthrough and Fast Track designations. Crofelemer's existing approval for HIV-related diarrhea underscores its safety profile.