Two Drugs in One: Synjardy Receives FDA Approval

Twitter Summary: BI + @Lilly_Diabetes receive @US_FDA approval for Synjardy: combines Jardiance + metformin into a single pill

The FDA recently approved Synjardy, which combines two diabetes drugs – metformin and Jardiance (an SGLT-2 inhibitor) – into a single pill. Synjardy is now the third SGLT-2 inhibitor/metformin combination pill to receive FDA approval, after J&J’s Invokamet (Invokana/metformin) and Astra Zeneca’s Xigduo (Farxiga/metformin). Synjardy is a twice-daily pill, similar to Invokamet and Xigduo, although Xigduo also comes in a once-daily version called Xigduo XR. Combination pills like Synjardy add a convenience benefit for patients, as they combine two pills in one, meaning fewer prescriptions to fill, fewer pills to take (particularly in the case of Xigduo XR), and only having a single co-pay. Pricing information for Synjardy is unavailable at this time, but it will probably be priced somewhere between Jardiance and BI/Lilly’s other new combination Glyxambi (Jardiance and the DPP-4 inhibitor Tradjenta).

So what exactly goes into Synjardy? SGLT-2 inhibitors, such as Jardiance, are a class of drugs that lower glucose levels by causing the kidney to excrete excess glucose through urine. They reduce A1c, cause very little hypoglycemia (none for most people), and can lead to weight loss and improvement in blood pressure. Metformin, alternatively, is a widely used treatment for type 2 diabetes known for its efficacy, safety, low cost, ease of use, and potential anti-cancer properties.

This approval comes on the heels of BI/Lilly’s recent groundbreaking announcement that Jardiance is the first diabetes drug to lower the risk of heart disease, leading to reduced risk of heart attack and stroke, making it a potentially attractive option for those at elevated risk of heart disease. We think it’s certainly very possible that all SGLT-2s will be shown to reduce heart disease though that will have to be proven in clinical trials. -AJW/ER