BioCentury
ARTICLE | Politics & Policy

CHMP considering changing indication for diabetes drugs

March 4, 2014 1:58 AM UTC

EMA's CHMP is seeking comments through June 3 on a proposal to simplify the label for Type II diabetes drugs "as a more relevant way of reflecting the intended use." Currently, a label specifies that the diabetes drug is indicated as monotherapy when diet and exercise alone do not provide adequate glycemic control in patients for whom metformin is considered inappropriate; and as add-on therapy with other glucose-lowering products, including insulin, when these products together with diet and exercise do not provide adequate glycemic control. ...