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Redeye comments on the positive opinion of the Committee for Orphan Medicinal Products concerning an orphan designation of nadunolimab in pancreatic cancer from yesterday. This news follows on the orphan drug designation from the FDA last month. Nadunolimab will now have orphan drug designation in pancreatic cancer in the two major regulatory areas in the world (after the final approval from EMA, expected within 30 days). The orphan drug designation in the EU is similar to the US one. We refer to our last note for more details. A major difference is the longer duration of the market exclusivity, which is 10 years in the EU.
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