The FDA approved Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, reversing its rejection of the product this spring based on quality concerns at one of BI’s plants where the drug is made.

Jardiance (empagliflozin) is indicated to improve glycemic control in adults with type 2 diabetes along with diet and exercise, the FDA last Friday. The approval was based on seven trials of 4,480 patients examining the drug, both alone or combined with metformin, sulfonylureas, pioglitazone and insulin. Trials showed improvements in HbA1c levels when compared with placebo, the companies said.

The drug can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes, the FDA said.  The agency is requiring four postmarketing studies:

• Completion of an ongoing cardiovascular outcomes trial;
• A pediatric pharmacokinetic/pharmacodynamic study;
• A pediatric safety and efficacy study, which will, in part, evaluate the effect on bone health and development; and
• A nonclinical (animal) juvenile toxicity study with a particular focus on renal development, bone development and growth.

In March, the FDA said it wouldn’t approve the drug until BI had addressed manufacturing issues at one of its plants. A European panel that month recommended approval. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.