DEERFIELD, Illinois—The Food and Drug Administration (FDA) has approved Takeda Pharmaceutical's febuxostat (Uloric®), the first new gout treatment in 40 years. Febuxostat 40 mg and 80 mg dosages are approved for chronic management of hyperuricemia in patients with gout. The drug is a next-generation nonpurine selective xanthine oxidase inhibitor.

“I think it's terrific news for gout patients and the physicians who treat them.”—Herbert S.B. Baraf, MD
“I think it's terrific news for gout patients and the physicians who treat them,” Herbert S. B. Baraf, MD, told MSKreport.com when news of the approval first broke. “It provides an option for the 12% of people with gout who can’t tolerate or don’t respond to allopurinol.” he said. Dr. Baraf is the medical director of the Center for Rheumatology and Bone Research, a practicing rheumatologist in Wheaton, Maryland, and a clinical professor of medicine at George Washington University Medical Center in Washington, DC.

Gout specialists waiting for pegloticase to join febuxostat

“Febuxostat is a very safe option for patients with standard, ordinary gout, but for those patients with extremely difficult gout, we are all waiting with baited breath for the approval of Pegloticase (Puricase®, Savient Pharmaceuticals, Inc),” Dr. Baraf added. Pegloticase is a recombinant, PEGylated formulation of a modified mammalian urate oxidase. A biologics license application (BLA) for pegloticase was filed with the FDA on October 31, 2008.

New gout education programs needed for new drugs

Pharmaceutical education programs often go hand-in-hand with new drug approvals. “There is an enormous need for better physician education in the management of gout and an educational push will likely follow [febuxostat’s approval],” Dr. Baraf said.

The phase 3 clinical trial, CONFIRMS, led to FDA approval. It showed that ULORIC 80 mg was superior to ULORIC 40 mg and allopurinol 300/200 mg at achieving the primary end point of serum uric acid less than 6.0 mg/dL at the final visit.

Febuxostat has been meandering down the pipeline for a while. The FDA’s Arthritis Advisory Panel had previously been concerned because early trials found a higher risk of death and heart problems associated with febuxostat, but a much larger clinical study commissioned by the company found that cardiac risk with febuxostat was not any higher than those with allopurinol.

Translating research into practice

No febuxostat dose adjustments are required in patients with mild-to-moderate renal or hepatic impairment. The study showed that the most commonly reported adverse reactions were liver function abnormalities, nausea, joint pain and rash.

“The approval of Uloric offers clinicians and their patients who have hyperuricemia associated with gout a new treatment option that helps prevent uric acid production," said Nancy Joseph-Ridge, MD, the president of Takeda Global Research & Development Center, Inc, in Deerfield, Ill.

Febuxostat was approved earlier this year by the European Medicines Agency (EMEA) and is marketed there by Ipsen, an international specialty pharmaceutical group, as Adenuric.

References
1. Takeda Pharmaceutical Company Limited. Press Release. FDA Approves ULORIC (Febuxostat) for Chronic Management of Hyperuricemia in Gout Patients. Distributed Feb. 16, 2009.