Eli Lilly (LLY) and Boehringer Ingelheim recently submitted a New Drug Application (:NDA) for their type II diabetes candidate, empagliflozin, in the US. Earlier this year, Eli Lilly and Boehringer Ingelheim had announced positive top-line results on empagliflozin from four phase III trials. Empagliflozin (10 and 25 mg taken once daily), a sodium glucose co-transporter-2 (SGLT-2) inhibitor, was found to be more effective in lowering blood sugar levels compared to placebo.
Meanwhile, the companies also announced that their marketing authorization application (MAA) for empagliflozin has been accepted for review by the European Medicines Agency (:EMA). We note that Eli Lilly is not the only company looking to develop a SGLT-2 inhibitor. In fact, Johnson & Johnson (JNJ) recently gained FDA approval for its SGLT-2 inhibitor, Invokana.
Eli Lilly currently carries a Zacks Rank #2 (Buy). We are pleased with the company’s efforts to strengthen its diabetes franchise. Eli Lilly’s diabetes franchise consists of products like Humulin, Humalog, and Tradjenta among others.
Last month, Eli Lilly and Boehringer Ingelheim had announced the commencement of a phase IIIb study with Tradjenta in type II diabetes patients with prevalent albuminuria who are currently receiving standard treatment for diabetic nephropathy.
The 24-week, multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study, MARINA (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin), will evaluate the glycemic efficacy and safety of once-daily Tradjenta (5 mg). The study is slated to complete in 2014.
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