New Drug for the Treatment of Gout

This Tuesday, a federal advisory committee recommended the approval of Krystexxa, a new drug that has been in development by Savient Pharmaceuticals. In clinical trials, the drug has shown to be an effective treatment for gout.

The committee recommended the approval by a landslide 14-1 vote. The drug now must be approved by the Federal Drug Administration (FDA) before Savient can begin producing, distributing, and marketing the drug. In the past, the FDA has been known to follow the advice of the advisory committees. If Krystexxa is approved, it will be the second drug for the treatment of gout approved this year, after 40 years without innovation in this particular area. Uloric, which is manufactured by Takeda Pharmaceutical, was approved for use in February.

Gout, which is a form of arthritis, is caused by a buildup of uric acid in the body. This uric acid can then be deposited in the joints. The deposits are known as tophi. The big toe is particularly susceptible to this searing pain caused by tophi, but other joints, including joints in the hands and elbows can also be affected.

The uric acid that builds up in the body is commonly associated with diet, as it is a metabolism defect. Foods such as alcohol (especially beer), red meat, and some seafood are commonly associated with gout. For this reason, gout has often been referred to as the “disease of the kings”, as these foods were historically only available to the wealthy. However, these foods have become more and more accessible to a larger percentage of the population, making gout more common, and less known as a disease of the rich. Increased incidence of gout has sparked a new interest in the medical research community.

Krystexxa is a form of uricase, an enzyme responsible for degrading uric acid in the body. The drug works by attacking the tophi, and helping to dissolve the deposits. In clinical trials, about forty-percent of patients saw significant improvement while taking the drug. Some patients reported that the tophi dissolved completely, and that they were able to walk and use their hands again without pain.

There are some side-effects that have been reported with the use of Krystexxa, including an increase in the prevalence of cardiovascular complications and allergic reactions. Committee members state that it is unclear whether the increase in cardiovascular conditions, however, is due to the drug or due to chance, based on the small trial size. The FDA, nevertheless, is expected to approve the drug, as the striking benefits for patients with chronic gout outweigh the side-effects.

Central Florida Foot & Ankle Center, LLC
101 6th Street N.W.
Winter Haven, FL 33881
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