Recently, Savient Pharmaceuticals, Inc. (BLA) announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for its gout candidate, Krystexxa (pegloticase). The BLA was resubmitted by Savient on March 15, 2010. A response from the FDA should be out in the fourth quarter of 2010 (target date: Sept 14, 2010).
As a reminder, the FDA issued a complete response letter (CRL) in July 2009 whereby the agency refused to approve the BLA for Krystexxa because Savient changed the way the drug was manufactured, among other issues.
The resubmission is classified by the FDA as a Class 2 review. The resubmitted application is inclusive of additional chemistry, manufacturing and controls, Safety Update, Labeling, Risk Evaluation and Mitigation Strategy, and Medication Guide, as requested in the complete response letter.
Savient is seeking approval of Krystexxa, a PEGylated uricase enzyme, for treating patients with chronic gout who do not improve with other treatments or cannot take the alternatives for various reasons.
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, intermittent attacks of severe pain and kidney damage. The incidence and severity of gout is increasing in the United States.
The market has a huge unmet need with Takeda’s Uloric (febuxostat), approved in Feb 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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