Hemispherx Biopharma Europe has secured a positive opinion from the Committee on Medical Products (COMP) regarding its orphan medicinal product application for Alferon N Injection for the treatment of Middle East Respiratory Syndrome (MERS).
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MERS was initially found in Saudi Arabia in 2012. It is an illness caused by a coronavirus known as the Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Hemispherx said infection can cause severe acute respiratory illness with symptoms of fever, cough, and shortness of breath as well as death.
The company noted that some people infected developed pneumonia with gastrointestinal symptoms including diarrhea, nausea/vomiting, and kidney failure.
The fatality rate of MERS is 38% and the mean time from onset to death is 12 days.
Hemispherx president Tom Equels said: "Alferon has great experimental potential as an early onset therapeutic for this dread disease. Hemispherx is dedicated to making Alferon available for MERS clinical trials, emergency uses and early access programs consistent with all applicable laws.
Alferon N is presently approved for sale in the US to treat refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age or older.
Hemispherx’s products include Alferon N Injection and the experimental therapeutics Ampligen and Alferon LDO.
Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome.