EMA Makes Orphan Drug Recommendations

News
Article

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP’s recommendations were four designation applications for rare forms of lipodystrophy.

The COMP meeting also confirmed Vertex Pharmaceuticals's Kalydeco (ivacaftor) for orphan designation. The confirmation follows the recommendation made by EMA’s Committee for Medicinal Products for Human Use (CHMP). Based on CHMP requirements, COMP confirmed that “Kalydeco continues to fulfill the orphan designation criteria.” COMP will publish the review of Kalydeco’s orphan designation after the European public assessment report for the drug is published.

COMP’s recommendations will be sent to the European Commission for adoption. Sponsors will have access to certain incentives during development once the orphan designation is granted.

A full list of COMP’s recommendations can be found in COMP’s monthly report.

Recent Videos
Drug Digest: Strategic Partnerships
Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.
Henny Zijlstra from Adragos Pharma chats about the trends affecting the outsourcing market, various strategies being employed by service providers, and the value of end-to-end services.