EMA changes orphan designation policy for certain eye drugs to expand access
The European Medicines Agency said yesterday that it’s changing how it signs off on orphan designations for drugs targeting inherited retinal dystrophies (IRD) in order to make sure that patients are not left out because of the limitations of the previous orphan designation terms.
Inherited retinal dystrophies are a group of genetic and progressive blinding diseases.
The Committee for Orphan Medicinal Products for the EMA announced the changed policy, which the organization said was supported by input from experts and patients of IRD, as well as a review of scientific literature and 64 active orphan designations in the specific eye diseases in the EU.
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