EU Court Ruling Puts Pressure On Orphan Drug Developers
Executive Summary
A recent ruling by the EU’s General Court has backed a decision to strip BMS’s multiple myeloma drug Empliciti of its orphan status on the grounds that it did not offer a “significant benefit” over Amgen’s Kyprolis. The case highlights the difficulty of providing convincing evidence of comparative benefit amid the growing number of orphan drugs coming through the development pipeline.
You may also be interested in...
Court Ruling A ‘Sea Change’ For EU Orphan Designation
A 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.
EU Ruling Raises New Questions For Orphan Designation
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.
Changes To EU Pharma Reform: More Questions Than Answers?
In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.