Northfield's long and difficult quest to win approval for the blood substitute PolyHeme was dealt another blow today as the FDA rejected the company's drug. Risks of the blood product outweigh its benefits, said the agency, noting that a greater number of patients given PolyHeme died after 30 days than those giving regular blood. The FDA also said that the information in the company's BLA is "inadequate for final approval action," and the Phase III study "did not meet the pre-specified primary efficacy endpoint."
The company has spent 20 years developing the blood substitute, including two years of frustrated attempts to gain approval of the drug. Northfield's future hinges on approval of PolyHeme, as it has no other drugs on the market. In a statement, all Northfield would say is that it is evaluating the FDA's response and considering the options for the company going forward.
- take a look at Northfield's release [1]
- see TheStreet article [2]
Related Articles:
Mortality data crushes Northfield stock value [3] (2007)
Northfield controversy grows over trial data [4] (2008)
Northfield shares hammered on late-stage data [5] (2006)
Links:
[1] http://www.fiercebiotech.com/press-releases/northfield-receives-complete-response-letter-polyheme-r-bla
[2] http://www.chicagotribune.com/business/chi-fri-northfield-blood-substitmay01,0,3166888.story
[3] http://www.fiercebiotech.com/story/mortality-data-crushes-northfield-stock-value/2007-05-23
[4] http://www.fiercebiotech.com/story/northfield-controversy-grows-over-trial-data/2006-02-24
[5] http://www.fiercebiotech.com/story/northfield-shares-hammered-on-late-stage-results/2006-12-20