Island Pharmaceuticals Wins FDA Orphan Drug Status for Galidesivir Against Marburg Virus

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Island Pharmaceuticals has received orphan drug designation from the U.S. Food and Drug Administration for Galidesivir in the post-exposure prophylaxis of Marburg virus disease. The antiviral agent, originally developed by BioCryst Pharmaceuticals for Hepatitis C, is now being explored for Ebola and Marburg viruses. The company previously entered a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases to acquire non-human primates for an optimization study, and has begun a GMP review for manufacturing and pivotal studies that could accelerate approval under the FDA Animal Rule pathway. Marburg virus, transmitted by fruit bats or infected individuals, has caused outbreaks in several countries including Germany, Serbia, Uganda, Ghana, Kenya, Rwanda, and most recently Tanzania, with mortality rates reaching 88% without proper care and an average fatality rate of 50%. No approved vaccines or antiviral therapies exist exclusively for Marburg virus disease. Island Pharmaceuticals shares were trading at AU$0.37 on the Australian Securities Exchange, up 4.23%.

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FDA orphan drug designation for Galidesivir against Marburg virus, a key regulatory milestone.

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