BOSTON, Oct. 26 /PRNewswire/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released a new white paper entitled Drug Innovation, Approval, Market Access, and the "New Normal": Emerging FDA Review Outcome Trends for New Drugs. Exploring trends in the review of new molecular entities (NMEs), as well as first-cycle approval and priority designation rates, PAREXEL Consulting's analysis indicates that there is a "new normal" emerging in the drug review and approval process.
PAREXEL Consulting's analysis identified notable declines in both first-cycle approval rates for priority drug applications and priority designation rates for new drugs at the time when the U.S. Food and Drug Administration (FDA) settled into its FDA Amendments Act (FDAAA)-related responsibilities and the 21st Century Review Process. Between 2008 and 2009, for example, PAREXEL Consulting found that there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications (NDAs).
"First-cycle approval rates are a key indicator of the biopharmaceutical industry's success in securing FDA approval for new therapies early in the review process. While there is often some fluctuation in first-cycle approval rates year-to-year, our analysis of the latest FDA metrics leads us to ask whether there is a 'new normal' emerging, which has significant implications for the drug-review process," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting.