Savient Pharmaceuticals Inc. (SVNT), after meeting officials from the U.S. Food and Drug Administration (FDA) on Monday, announced that the agency does not expect further clinical trials to be conducted for its gout drug Krystexxa, as the company has now reverted to its original manufacturing process for producing phase III trial material for Krystexxa.

The meeting discussed the Complete Response Letter (CRL) received on July 31, 2009 from the FDA, whereby the agency refused to approve the Biologics License Application (BLA) for Krystexxa (pegloticase) because Savient changed the way the drug was manufactured, among other issues. As a result of this ruling, Savient stated that it can meet its previously announced timeline of filing the resubmission in response to the CRL in early 2010 .The resubmission will be classified as a Class 2 review, with a possible approval in the third quarter of 2010.
 
As a reminder, Krystexxa, a PEGylated uricase enzyme, is being developed for patients with chronic gout who do not improve with other treatments or cannot take the alternatives for various reasons.
 
An estimated 3-5 million people in the United States and approximately 5 million people in the European Union suffer from gout, which is the most common form of inflammatory arthritis in men over 40. Of those, about 40,000 to 60,000 do not respond to other therapies. The incidence and severity of gout is increasing in the United States. There was a 288% increase in gout-related hospitalizations from 1988-2005.

Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. This causes deposition of uric acid crystals in and around the connective tissue of the joints and in kidneys, leading to inflammation, formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares) and kidney damage (nephropathy).

The market has a huge unmet need with Takeda’s Uloric (febuxostat), approved in February 2009, being the only new drug to be approved in the United States for the treatment of gout in the last 40 years. Ardea Biosciences (RDEA) is developing RDEA594 to combat this painful disease.
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