FDA Rejects New Diabetes Drug, Empagliflozin
The Food and Drug Administration rejected Eli Lilly’s and Boehringer’s petition for their new diabetes drug, empagliflozin.
Reasons for FDA Rejection of Diabetes Drug
According to Reuters, the FDA believes that there are problems at the Boehringer factory in Ingleheim, Germany where empagliflozin is being made.
In May of 2013, the FDA issued a warning letter to the pharmaceutical company in connection to multiple problems they had found in an inspection six months earlier. One of the issues is that the FDA found foreign matter in active pharmaceutical ingredients.
The FDA does not believe that the company has fully resolved these issues and has refused to approve the product until Boehringer complete a series of updates and fixes.
How is Boehringer Fixing the Problem?
The company is making new renovations in its German factory and are upgrading processes and systems
They are also hiring 200 new specialists, putting in better employee training as well as improving management structure
The FDA is in the midst of inspecting the plant once again and the company believes their drug will get approved sometime later in 2014, especially since they have not been asked for new clinical trials of the drug.
The Drug: Empagliflozin
- The drug is part of a class called SGLT2 inhibitors. These drugs work by blocking the kidney from reabsorbing blood sugar, which leads to glucose being removed from the body in urine
- Johnson and Johnson recently released a similar drug onto the market already; it is called Invokana.
- Though still in clinical trials, data has linked empagliflozin to an increase rate of genital infections, especially among women.