Hemispherx Biopharma Receives EMA Orphan Status for Ebola Drug
The European Medicines Agency has granted orphan medicines designation to Hemispherx Biopharma Europe’s experimental Ebola treatment Ampligen.
The designation makes the drug eligible for EU-level grants and member state programs, as well as assistance with protocol design. If commercially approved, orphan drugs receive 10 years of market exclusivity.
Thomas Equels, the company’s executive vice chairman, called the EMA decision an important step in the path to commercial development of Ampligen (rintatolimod) as a prophylactic and early onset therapeutic in patients diagnosed with the Ebola virus.
The EMA has encouraged companies developing potential Ebola treatments and vaccines to seek early dialogue with the agency through its orphan designation and scientific advice program to establish viable development plans. — Jonathon Shacat