Approval of Diabetes Drug Shelved Indefinitely by FDA
Health officials have denied approval of a revolutionary type of diabetes treatment drug due to inadequate production conditions.
The drug, empagliflozin, is a member of a new class of revolutionary diabetes treatment options known as SGLT2 inhibitors. These inhibitors prevent the kidney from reabsorbing/retaining excess blood sugar, encouraging the removal of glucose through the urine. This helps patients with diabetes, a condition where the body has trouble processing sugar, resulting in excess buildup of unprocessed glucose.
Johnson and Johnson recently had their own rendition of this drug treatment, called invokana, approved by the FDA for distribution in the U.S.
Eli Lilly & Co.'s empaglifozin, was slated to be the next version of this kind of new diabetes drug to hit the U.S. market, but it's approval has been suspended indefinitely after regulators found that manufacturing problems first brought to the drug producer's attention back in 2012 had yet to be adequately addressed.
According to FDA records, the 2012 inspection found violations including contamination problems and inconsistencies with the drug's active ingredients when mass-produced. These problems, associated with a manufacturing plant in Germany, were supposed to have been addressed prior to a re-inspection by FDA officials at the start of this year; they had not been.
According to a response letter to the Boehringer Ingelheim manufacturing facility -- in association with Eli Lilly & Co. -- where empaglifozin will be manufactured, the FDA will not approve the drug until the cited problems are fixed. Health officials are also asking for a follow up examination of both the production of the drug, and the drug itself, ensuring that it is perfectly safe for U.S. diabetes sufferers.
According to the Centers for Disease Control and Prevention, approximately 25.8 million people -- 8.3 percent of the U.S. population -- suffer from diabetes in the U.S.
The FDA's Complete Response Letter to Eli Lilly & Co. was released on March 5.
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