|Wednesday, 04 March 2009 08:06|
WASHINGTON, March 3 (Reuters) - U.S. regulators will ask outside advisers for input on safety concerns surrounding expanded use of AstraZeneca Plc's (AZN.L) schizophrenia drug Seroquel XR, the Food and Drug Administration said on Tuesday.
The issues for discussion at the April 8 advisory panel meeting include "concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia," an FDA notice said.
Tardive dyskinesia causes involuntary, repetitive movement of the limbs and lip smacking, grimacing and other symptoms that can be permanent.
Seroquel is AstraZeneca's second-best-selling drug, with $4.5 billion in 2008 sales. Seroquel XR is an extended release version of the medicine with a longer patent life than the original formulation.
AstraZeneca is seeking FDA approval to market Seroquel XR for treating depression and anxiety. The drug is already sold for treatment of schizophrenia and bipolar disorder. Those already-approved uses are not a part of the advisory committee review, AstraZeneca spokeswoman Abigail Baron said.
"AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and risks of Seroquel XR in the treatment of major depressive disorder and generalized anxiety disorder," she said.
Seroquel's prescribing instructions include warnings about weight gain and diabetes as well as increases in cholesterol levels. Tardive dyskinesia also is mentioned as a possible complication.
The FDA will consider the advisory panel's recommendations before deciding whether to approve the new uses. The agency usually follows the advice of the outside panels. (Reporting by Lisa Richwine, editing by Gunna Dickson and Gerald E. McCormick)