Hemispherx Biopharma, Inc. (HEB) announced it has submitted an application for orphan drug designation to the European Medicines Agency for Alferon N Injection, an experimental therapeutic, to treat Middle East Respiratory Syndrome. The company reported that the EMA has determined the application to be valid, and the Committee for Orphan Medicinal Products has initiated the official review process.
Hemispherx said its Alferon N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
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