Rare diseases are pathologies that affect less than 5 out of every 10,000 inhabitants in the European Union and less than 200,000 people in the United States.
Both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) offer a series of economic and strategic advantages for companies wishing to develop an orphan drug.
Orphan drug designation can be applied for at any stage of product development, provided that there is sufficient information (empirical and/or bibliographic) to demonstrate that our product could be effective in the treatment of the disease for which we are applying for orphan designation.