Orphan drug designations in decline in EU and USA

28 February 2020

The development landscape for orphan drug developers has often been painted as attractive in recent years because of the schemes that regulators offer for these much-needed therapies.

Research from GlobalData has shown that the picture is not necessarily so rosy, reflecting a decline in the number of drugs awarded orphan drug designations (ODDs) by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) over the last six years.

While in the USA, the six-year period has been one of ups and downs in terms of the number of ODDs being handed out, in Europe, overall there has been a steady decline, as evidenced by the below table.

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