The US Food and Drug Administration has decided against approving Uloric (febuxostat), a drug for gout developed by Takeda Abbott Pharmaceuticals, a joint venture between Abbott Laboratories and Takeda Pharmaceuticals, for the second time.
The FDA issued another ‘approvable’ letter for febuxostat, which is also being developed in Europe by French drugmaker Ipsen. The reasons behind the agency’s decision have not been made public, although there has been speculation that the FDA is not convinced by the effect on reducing gout flares seen in clinical trials.
TAP originally filed for approval of febuxostat in the USA in December 2004, but received a first approvable letter asking for additional information in October 2005. It responded to this request earlier this year, and had been hopeful of securing approval before the end of the year.
The continued delay could be good news for rival company Savient Pharmaceuticals, which has another gout treatment in Phase III testing. Puricase (PEG-uricase) is due to be filed for approval next year, with a possible launch in 2009.
Abbott said the FDA's decision would have no impact on its 2006 earnings guidance. Meanwhile, analysts at JP Morgan said the impact of the delay would be minimal, predicting sales of $125 million next year doubling up to $250 million in 2009.
There have been no significant advances in the management of gout - a disease in which uric acid levels are elevated in the body, leading to the precipitation of crystals in joints and other parts of the body which in turn cause inflammation and pain - in the last 40 years.