Eli Lilly's Diabetes Drug Approval Halted by FDA over Facility Quality Issues

The U.S Food Administration declined to approve Eli Lilly's new diabetes drug empagliflozin, citing quality issues at the German factory where the drug will be made, Lilly along with its partner Boehringer Ingelheim said Wednesday.

The drug's sponsors said in a joint statement that FDA has issued a complete response letter for the New Drug Application (NDA) for empagliflozin.

The FDA issued a warning letter to Boehringer-Ingelheim, May 2013. The agency found poor manufacturing standards at the factory where the drugs are to be produced, Reuters reported.

In one such notice, FDA had found contaminants in active ingredients used in certain drugs.

The agency has asked the Boehringer Ingelheim facility to resolve the contamination issues before an approval can be issued, Lilly said in a statement. The large-scale NDA process was based on over 10 multinational trials involving data from over 13,000 people with type-2 diabetes

Boehringer said that it is upgrading the facilities to meet FDA criteria, Reuters reported.

The experimental drug- empagliflozin is for people with diabetes type-2 and belongs to a class of drugs called sodium glucose co-transporter-2 (SGLT2) inhibitor. The drug works by removing excess glucose through urine. These drugs block glucose re-absorption by the kidneys.

Alex Arfaei, an analyst with BMO Capital Markets, told Reuters that he expects FDA to approve empagliflozin this year and that the drug will generate $1.6 billion for Lilly.

Diabetes type-2 is a chronic condition where the body is unable to use the hormone insulin, leading to an increase in glucose levels in the blood. Some 24.4 million Americans and an estimated 382 million people around the world have either diabetes type-1 or type-2.

Several pharmaceutical companies are in the race to produce a drug that could help people with diabetes type-2 control their blood sugar levels. Recently,Johnson & Johnson's new diabetes drug Invokana- also from SGLT2 class - was approved by FDA.

However, there are studies that are now showing that this newest class of diabetes drug might lead to an increase in glucose production by the body.