- Significant milestone for Jaguar Health (JAGX, Financial) as FDA discusses potential approval pathways for crofelemer.
- Breast cancer patient subgroup in Phase 3 trial showed statistically significant improvement in diarrhea response.
- Jaguar Health plans to seek orphan drug designation and potentially expedite approvals through Breakthrough Therapy and Fast Track designations.
Jaguar Health, Inc. (JAGX) has announced substantial progress in its ongoing efforts to bring crofelemer, a drug aimed at addressing cancer therapy-related diarrhea (CTD), closer to approval. Following a productive Type C meeting with the U.S. Food and Drug Administration (FDA), the company outlined two potential pathways for crofelemer, specifically targeting metastatic breast cancer patients: conducting a pivotal treatment trial and launching an expanded access program.
While the Phase 3 OnTarget trial did not meet its primary endpoint across all cancer types, it showed statistically significant results in a breast cancer patient subgroup, with 183 of the 287 participants showing notable improvement in diarrhea response compared to placebo. This promising outcome has prompted Jaguar Health to refine its approach, focusing on the breast cancer subpopulation.
As part of its regulatory strategy, Jaguar Health intends to seek orphan drug designation for crofelemer, a status that could provide significant benefits, including tax credits for clinical testing and a seven-year period of marketing exclusivity upon approval. Additionally, the company is considering applications for Breakthrough Therapy and Fast Track designations, which could potentially shorten the time to market.
Crofelemer, already on the market since 2012 for HIV-related diarrhea, has demonstrated a robust safety profile with no serious adverse events reported, enhancing its viability for regulatory approval. Jaguar's efforts represent a focused approach to meeting an unmet medical need, and the company anticipates submitting a pivotal trial protocol to the FDA while proceeding with expanded access efforts.
Jaguar Health's strategic focus on orphan diseases aligns with regulatory trends and could expedite the approval of crofelemer for CTD in metastatic breast cancer patients, addressing a significant gap in cancer care.
