NEW YORK, Nov 20 (Reuters) - New data do not signal any heart risks with Takeda Pharmaceutical Co Ltd’s (4502.T) experimental drug to treat acid build-up in patients with gout, a top U.S. Food and Drug Administration official said in a document released on Thursday.
Takeda is seeking U.S. approval to sell its drug febuxostat for chronic gout patients with hyperuricemia, a build up of uric acid that can lead to swollen joints and arthritis flare-ups. The company earlier had proposed the trade name Uloric.
The document was released ahead of an FDA advisory panel meeting on Monday to discuss whether or not the agency should approve the drug.
The Japanese drug maker first sought U.S. approval in 2004, but the FDA requested additional data after its review of two late-stage clinical trials raised concerns about possible heart risk, according to the documents.
“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 an additional trial to address safety and plans to present the findings at Monday’s meeting, he said.
“This new study did not show a cardiovascular safety signal,” Rappaport wrote.
The agency will weigh the advice of its outside advisors before later making its final decision.
Still, while the FDA “does not dispute efficacy of febuxostat,” it does plan to “focus on safety issues” at the meeting.
If the FDA approved the drug, it would be the second xanthine oxidase inhibitor marketed in the United States, according to the agency.
Other types of drugs used to treat gout include non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, among others, according to the agency’s website.
In separate documents also released on Thursday, Takeda said “clinicians need a more potent and tolerable agent that is efficacious in treating all patients with gout,” especially those with kidney problems or who are not helped by current therapies.
Between 3 million and 5 million Americans have the condition, it said.
The company studied 4,072 patients who received at least one dose of the drug. Data showed it was well-tolerated in patients taking it for up to 5 years, with upper respiratory tract infections the most commonly reported side effect, it said.
On Monday, the FDA plans to ask its advisers whether the evidence points to any heart risk in certain doses of the drug as well as whether gout patients with kidney problems have an urgent need for such treatments.
Shares of Takeda earlier closed down about 4 percent on the Japanese market. (Reporting by Susan Heavey, editing by Gerald E. McCormick)