FDA approval drought despite surge in apps

The long drought of FDA approvals for new molecular entities is occurring despite some big efforts by drug developers to push through new drugs. In a new study examining NME approvals for 2007, Parexel noted that approvals scraped the bottom of the record books at 16. But applications jumped 33 percent last year. Approvals of therapies with a new active substance (an NAS), declined 19 percent last year, while applications jumped from 21 to 28.

"NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions," said Mark Mathieu, Parexel's director of publications and editor of The US Drug Approval Trends and Yearbook 2008/2009. "The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use."

- here's Paraxel's release [1]
- check out the report [2] from the Boston Globe

Related Articles:
FDA picking up the pace on '08 approvals [3]
2007 FDA approvals [4]
2008 NME approvals no better than last year? [5]
Dry spell or parched desert for NME approvals? [6]