FDA spurns Lilly, Boehringer diabetes drug, cites factory problem

(Reuters) - Eli Lilly and Co and partner Boehringer Ingelheim said U.S. regulators have declined to approve their experimental diabetes drug empagliflozin, citing previously observed problems at a facility where it would be made. The drugmakers, in a joint release on Wednesday, said the U.S. Food and Drug Administration determined that undisclosed issues at the Boehringer Ingelheim factory need to be resolved before the product could be approved. The drug is a member of a new class of diabetes medicines known as SGLT2 inhibitors, which block the kidney from reabsorbing blood sugar, thereby spurring removal of glucose through the urine.



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