Orphan drug designation

Rare diseases are those that affect fewer than 5 in 10,000 inhabitants in the case of the European Union, and fewer than 200,000 people in the United States.

Both the European Medicines Agency (EMA) and the U.S. (FDA) offer economic and strategic benefits for companies who want to develop an orphan drug.

The Orphan Drug Designation (ODD) can be applied at any time during the product development, provided that we have sufficient information (empirical and/or literature) to show that our product may be effective in treating the disease for which orphan designation is requested.

If you’re developing a drug to treat an orphan disease and you want support to be granted with ODD, please contact us!