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| |  European Union Grants Orphan Drug Status To Virazole (Ribavirin) For Hemorrhagic Fever COSTA MESA, CA -- March 16, 2001 -- ICN Pharmaceuticals, Inc. announced that the European Commission has granted Orphan Drug Status designation in the European Union to intravenous Virazole® (ribavirin) (100mg/ml) for the treatment of hemorrhagic fever with renal syndrome following a positive opinion from the European Medicines Evaluation Agency (EMEA). Hemorrhagic fever with renal syndrome is recognized by the World Health Organization as the clinical designation for a form of acute disease produced by Hantaan and related viruses. It is endemic in a belt from Norway through Sweden, Finland and Russia to Japan. Overall mortality has been reported between 5 percent and 15 percent, although rates of up to 32 percent have been reported. Symptoms can include fever, nausea, vomiting, renal decline and secondary bacterial infection. Orphan-Drug status designation is granted for rare diseases or conditions. In the European Union such designation is provided after demonstration that a drug has efficacy for the indication as in the case of intravenous ribavirin (Virazole) by a seven-fold reduction in mortality risk (Higgins, JW, The Journal of Infectious Diseases, 1991; 164:1119-27), and that the prevalence of the condition is fewer than five per 10,000 population. There is no current therapy for hemorrhagic fever with renal syndrome in the European Union. Following this Orphan-Drug designation, ICN intends to file for an EMEA Marketing Authorization for a medicinal product for intravenous ribavirin (Virazole) treatment for hemorrhagic fever with renal syndrome. Upon successful regulatory acceptance of the application, ICN will obtain market exclusivity for 10 years within the European Union. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status to intravenous ribavirin (Virazole) for Korean hemorrhagic fever. Discovered and developed by ICN scientists, the broad spectrum anti-viral drug ribavirin is currently licensed to Schering-Plough Corporation for use in capsule form (Rebetol) as treatment for patients with chronic hepatitis C in combination with Intron A (interferon alfa-2b, recombinant) as Rebetron™ combination therapy. Ribavirin is marketed in the United States and the European Union as Virazole for aerosol use in the treatment of hospitalized infants and young children with lower respiratory tract infection from respiratory syncytial virus (RSV), and is marketed in a total of 44 countries in a variety of forms around the world for 10 different viral indications. In the United States, the indication for hemorrhagic fever with renal syndrome is not an FDA approved use of intravenous ribavirin (Virazole). Related Link: ICN Pharmaceuticals, Inc.
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