No heart risk seen with Takeda gout drug: FDA

NEW YORK (Reuters) - New data do not signal any heart risks with Takeda Pharmaceutical Co Ltd’s 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)

Source

--------------------------------------------------------------------------------------------
Related Posts:


By Susan Heavey WASHINGTON (Reuters) - Data show Novartis AG’s combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday. “The majority of AEs (adverse events) were of mild or moderate intensity. Deaths … and SAEs (serious adverse events) … were

Full Post: Novartis malaria drug safe, effective: FDA
--------------------------------------------------------------------------------------------

By Lisa Richwine WASHINGTON (Reuters) - U.S. regulators remain concerned about serious risks from a class of asthma drugs and will ask U.S. advisers next week if approval for treating the lung disease should be revoked, documents released on Friday said. Staff in the Food and Drug Administration’s drug-safety office unanimously recommended withdrawing the approval of all

Full Post: FDA sees asthma drug risks
--------------------------------------------------------------------------------------------

NEW YORK (Reuters) - The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration’s top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday. The agency is thinking about how to weigh such possible side effects

Full Post: Drugs’ heart risk is FDA’s biggest worry: official
--------------------------------------------------------------------------------------------

By Susan Heavey WASHINGTON (Reuters) - U.S. health regulators are questioning whether clinical trials proposed by ImClone Systems and Amgen Inc will be adequate to show that patients with a certain type of gene are more likely to be helped by two cancer drugs, according to documents released on Friday. Early research has indicated that patients with

Full Post: FDA questions Lilly, Amgen cancer drug trials
--------------------------------------------------------------------------------------------

WASHINGTON (Reuters) - A review of clinical trial data from four drugmakers shows no overall risk of heart problems in patients taking drugs to treat osteoporosis, the U.S. Food and Drug Administration said on Wednesday. The agency reviewed studies on Merck & Co’s Fosamax, Roche’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel and

Full Post: Studies do not link heart risk to bone drugs: FDA

Site Navigation

Most Read

Search