Univar’s Cufence Approved In EU For Wilson’s Disease, But Loses Orphan Status
Executive Summary
Cufence, which has just been authorized for EU-wide marketing, is one of two trientine products for Wilson’s disease to lose their orphan designation.
You may also be interested in...
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.
EU Approval Recommendations: Strong Showing From Orphans & Biosimilars
The CHMP has recommended 11 products for approval at its latest meeting, including four orphan medicines, three biosimilars and two generics. It also recommended harmonizing the product labeling for two etoposide products.
WHO Launches Twin-Track Procedure To Speed Access To Health Products
A procedure used to accelerate the approval of COVID-19 products during the pandemic is to be applied to all medicines using “synchronized and parallel, but otherwise entirely independent, processes,” the World Health Organization says.