FDA mulls killing Avandia safety study-WSJ
NEW YORK, April 18
NEW YORK, April 18 (Reuters) - U.S. regulators are considering ending a safety study on GlaxoSmithKline's (GSK.L) diabetes drug Avandia, the Wall Street Journal reported on Sunday, saying the move could also jeopardize the drug's presence in the U.S market.
Avandia has been in the spotlight because of concerns that the drug increases heart attack risks. U.S. Senators Max Baucus and Charles Grassley released a report on the drug in February as well as internal FDA documents, including a 2008 memo from two FDA drug safety reviewers who recommended pulling the drug from the U.S. market.
Glaxo has said the scientific evidence did not establish that Avandia increased heart attack risks and added it had been open in providing information about the drug.
According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.
FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."
Sharfstein said no decision had been made on the trial -- the FDA has asked a government scientific panel to review the ethics of head-to-head trials, the Journal said.
In late March, Saudi Arabia's Food and Drug Authority has suspended Avandia for six months, becoming the first healthcare regulator to take such action. The Saudi FDA argued that the potential heart risks of the drug outweigh its benefits.