Court Ruling A ‘Sea Change’ For EU Orphan Designation
Executive SummaryA ruling from the EU's top court says the European Medicines Agency was wrong to reject Shire Pharmaceuticals’ application for orphan designation for a new product on the grounds that the active substance it contained already had orphan status. The decision is seen as offering significant opportunities for the R&D-based pharmaceutical industry.
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An EU court has upheld a decision to revoke the orphan designation awarded to GMP-Orphan's trientine product for Wilson's disease, saying that the product no longer met the “significant benefit” criterion on the grounds of lack of availability of another drug. The case has raised questions about the level of evidence needed to justify a significant benefit.
The European General Court says that companies are entitled to an independent and new period of orphan market exclusivity for a product that is highly similar to a previously authorized orphan drug.