The Japanese pharmaceutical, Takeda, has been testing a new drug for use in treating . They had applied for approval by the U.S. Food and Drug Administration (FDA) in 2004, but the FDA had requested more data as a result of concerns about a possible increase in heart attack risk.
The drug is known as febuxostat and will be marketed under the trade name Uloric.
“Because of the small numbers of events in each study arm there was uncertainty concerning whether the adverse events represented a genuine safety signal or whether they may have occurred by chance,” Dr. Bob Rappaport, head of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products, wrote.
Takeda conducted a study of 4,072 patients who had received at least one dose of febuxostat. The results showed it was well tolerated in patients who took the drug for up to 5 years. The most common side effect was an upper respiratory infection.
In another recent study, a team from the University of Pennsylvania and the VA Medical Center in Philadelphia conducted a phase-III double blind study involving 1,072 people with hyperuricemia and . The participants received allopurinal, febuxostat or a placebo during a 28 week study period. The study pool included patients with normal and impaired renal function.
The results of this study showed that nearly half of the febuxostat group achieved the desired primary endpoint of less than 6.0 mg/dL serum urate level compared to 22% on allopurinal and none on the placebo. Among those participants with impaired renal function, 44% of the febuxostat group achieved the primary endpoint whereas none in this subgroup on allopurinal did.
The results of the University of Pennsylvania study were published on the November 15th issue of Arthritis Care & Research.