Human Genome (HGSI) Announces Resubmission of Raxibacumab BLA; PDUFA Date Set for Dec. 15th

Article Stock Quotes (1) Comments (0)

Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the U.S. FDA has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for raxibacumab, a treatment for inhalational anthrax, and has established December 15, 2012 as the Prescription Drug User Fee Act (PDUFA) action date.

The FDA has deemed the resubmission a complete, class 2 response to its November 14, 2009 complete response letter, which requested further analyses of existing data as well as additional information.

The BLA resubmission contains additional evaluation of histopathology of survivors and non-survivors in animal studies, evaluation of potential added benefit of using raxibacumab with antibiotics versus antibiotics alone, and additional validation to confirm previous data.

---

Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW

---

*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here

---

---

You May Also Be Interested In

• Merck (MRK) Says Efficacy Not Achieved in Preladenant Phase 3s; Will Discontinue
• Janssen Pharma (JNJ) Plans Slew of Filing, Extension Submissions by FY17
• Sprint (S), SoftBank Receive Final State Regulatory Approval in Proposed Deal

Create E-mail Alert Related Categories

Corporate News, FDA

Add Your Comment

Name

Subject

Body

Share on Facebook

Verification
can't see the text?
click here to refresh the image.
what's this?