Post by
QuercusAlba on Jul 11, 2015 9:16am
2014 BLA approvals by US FDA: time required
Here's a little tidbit for a Saturday morning.
In addition to the >100 drugs approved by the FDA last year is a much shorter list of 11 "BLA drugs".
Of the eleven, eight were reviewed on a priority basis.
With a little poking around you can come up with the application date when the Biologics License Application (BLAs) was filed for each of these.
From the earliest to latest applicant, approval took the following time (in months):
11.5, 23, 8, 8, 11, 6, 6, & 5.
Takeaway: FDA seems to be turning these around a bit faster.
No info on how many applied under BLA and didn't make it; so, no word on the odds of success.
Cheers,
QA
Link to complete list of drugs approved by FDA in 2014:
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM435753.pdf
Comment by
1wascallywabbit on Jul 11, 2015 9:42am
Q, are u saying 5 months from "filing" date is the quickest one? Are u sure it isn't 5 months from acceptance of that BLAfiling? We filed Jun 30. So 5 months is Nov 30. Or only 3 months after expected acceptance date. Would be nice. By the way, I expect acceptance in August. And i I expect an NR Tuesday before the conference call. Maybe a Partnership.....
Comment by
QuercusAlba on Jul 12, 2015 2:02pm
Sorry Bugs, haven't read any fine print / delved any deeper into this. Didn't see filing date mentioned, only application date and approval date. As you suggest the matter may be more complicated than that. QA