In this FDA Report Update, we evaluate the overall number of approvals using data from the U.S. Food and Drug Administration (FDA) on original new drug applications (NDA), new molecular entities (NME) and biologic license applications (BLA). Utilizing data from BioMedTracker, approval rates measuring the percentage of FDA actions that are approvals are presented.

Also in the report are sections on the 2010 PDUFA Performance Report, Food and Drug Administration Amendments Act (FDAAA) and Risk Evaluation and Mitigation Strategy (REMS) programs, as well as information gathered from our new BioMedTracker AdComm Insight feature detailing FDA advisory panel meeting results. In addition, we have included approval decisions by disease group, upcoming PDUFAs and the magnitude of price movements around PDUFA dates.

Key Points

• High number of NME, BLA approvals 2011 year-to-date (21 NME, 5 Biologics)
• High number is attributable to high approval percentage (78% in 2011 through Calendar Q3)
• Failing to gain initial review approval leads to an average of over 1 year (16.62 months) delay to market
• Very high (~85%) positive AdComm vote typically needed for approval, especially for 1st review approval
• Action dates missed and extensions continued to decline, possibly due to reduction in FDA workload
• Oncology leads approval decisions in calendar 2011 with an expected 33 original or supplemental filings decided upon by FDA
• High profile PDUFA decisions lead to significant % stock price moves, with several major upcoming PDUFA catalysts expected through 2011 and beyond

For the full report, please download the PDF version at the top of this page. For a copy of any charts found in the report in Excel format, please contact your sales representative.

For our disclosures, please read the BioMedTracker Research Standards.