FDA Breakthrough Therapy Designation and EMA PRIME Status


The PharmSource Lead Sheet continues to be an excellent source of valuable information on drug candidates that have been granted expedited development and review programs through the FDA and EMA, such as Orphan Drug Designation and Fast Track Designation.

We are excited to announce that the PharmSource Lead Sheet now provides information on FDA Breakthrough Therapy Designation in the US and EMA PRIME status in Europe.

Companies applying for this designation must meet two criteria for the drug: 1) it must have the goal of treating a serious or lethal disease, either as a stand-alone drug or together with one or more other drugs, and 2) indicate in preliminary clinical data that the treatment may be significantly more efficacious than current therapies in at least one clinically significant endpoint.

Here’s where to find this in the PharmSource Lead Sheet:

  1. On the weekly report, just above the comment section:
  2. As a new search criteria in the Search for Leads menu:
  3. In a column in the Excel spreadsheet when you download leads from the weekly report or the search feature:
  4. As a new search criteria in the Trend Report Graphs menu:

For questions about this feature or any other inquiries regarding the PharmSource Lead Sheet please contact me at +1.703.383.4903 ext. 106 | scotty@pharmsource.com

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

More posts by Scotty Chung-Siu