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Savient Pharmaceuticals has found a new
drug that may be used to treat serious cases of gout, a disease characterized
by excruciating, unexpected, burning pain, as well as redness, warmth and stiffness
in the affected joint. The drug, called pegloticase, helped remove uric acid,
which causes the painful crystals that are deposited on the articular cartilage
of joints, tendons and surrounding tissues.
During the annual meeting of the American College of Rheumatology, the company
presented data from five studies the pegloticase Phase 2 study, GOUT 1 and 2
studies (Gout Outcomes and Uric Acid Treatment) and 3, and a 12-month
non-interventional natural history study in treatment-failure gout patients.
While the drug proved to be effective in
treating patients with long-term gout who have not responded well to other
treatments, the side effects weren’t “favourable” for Puricase, analysts said. The
eight adverse effects included two cardiac arrests and one myocardial
infarction, or heart attack, but researchers couldn’t say definitely they were
caused by pegloticase. The company stated that patients with cardiovascular
serious adverse events were able to continue successfully treatment. None of
the event was thought to be casually related to treatment with pegloticase.
Gout, also called metabolic arthritis,
affects approximately 1 in 40 people worldwide. An estimated 2 million to 3
million in the U.S.
have the condition.
“There hasn't been a new drug for gout in
the U.S. for over 40 years,”
said Dr. John Sundy, a rheumatologist at Duke
University Medical
Center in North Carolina and lead-author of the study.
The company is planning to file Biologics License
Application with the FDA by the end of this month.
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