WASHINGTON -- ICN Pharmaceuticals Inc. has submitted a newdrug application to the Food and Drug Administration for itsanti-viral drug Virazole for treating hemorrhagic fever withrenal syndrome (HFRS).
In May, the FDA granted Virazole orphan drug designation forthe treatment of HFRS, which is caused by the Hantaan virusand can cause severe shock, internal bleeding and kidneyfailure.
ICN estimates there are 150,000 cases of HFRS worldwide.There are no competing treatments, according to spokesmanJack Sholl.
The NDA contains supporting data from a U.S. Army clinicalstudy conducted in China on the use of injectable Virazole fortreating HFRS and clinical support data from South Korea. ICNplans to use this data to support submissions to regulatoryauthorities in other countries where HFRS is prevalent, Shollsaid.
ICN submitted the NDA through Viratek Inc., a pharmaceuticalresearch and development company that is 83 percent owned byICN. Viratek holds the patent for Virazole, while SPIPharmaceuticals Inc. is licensed to market the drug.
ICN, based in Costa Mesa, Calif., is also developing Virazole fortreatment of HIV, hepatitis C and pediatric influenza.
Virazole is available as an aerosol treatment in the UnitedStates and 18 other countries for infants with severe lunginfection caused by respiratory syncytial virus. It is alsoauthorized in 40 countries outside the United States indifferent formulations for a variety of other viral infections,including influenza, measles, herpes simplex and AIDS.
"We are attempting to determine which compounds and whichindications have the greatest commercial potential, and whichof these we should develop ourselves and which might belicensed out to other companies and partners," Sholl said.
-- Kris Herbst BioWorld Washington Bureau
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