Jaguar Health Announces Submission Of Orphan Drug Designation Application To The FDA For Crofelemer For Cholera-Related Diarrhea
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Jaguar Health (NASDAQ:JAGX) has submitted an Orphan Drug Designation application to the FDA for crofelemer for cholera-related diarrhea. Crofelemer, a plant-based prescription drug, aims to treat moderate-to-severe diarrhea from various infections, including cholera. The company has previously received ODD for crofelemer for short bowel syndrome and microvillus inclusion disease. Jaguar expects results from 5 proof-of-concept studies in 2024 and 2025, with potential early patient access in Europe in 2025. The FDA activated an IND application for crofelemer in August 2023. ODD could provide development incentives and a seven-year marketing exclusivity in the U.S.
February 12, 2024 | 1:35 pm
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Jaguar Health's submission of an Orphan Drug Designation application for crofelemer for cholera-related diarrhea could lead to development incentives and a seven-year marketing exclusivity in the U.S.
The submission of the Orphan Drug Designation application by Jaguar Health for crofelemer for cholera-related diarrhea is a significant regulatory step that could lead to development incentives, including tax credits and relief of filing fees, as well as a seven-year period of marketing exclusivity in the U.S. if approved. This exclusivity and the potential for early patient access in Europe in 2025 could significantly impact Jaguar Health's market position and financial performance in the short term.
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