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BI/Lilly Launch Jardiance for Type 2 Diabetes – Now the Third Commercially Available SGLT-inhibitor in the US

Twitter summary: BI/Lilly launch Jardiance in the US, making it the 3rd SGLT-2 inhibitor on the market; savings program for one-year free supply

After its recent FDA approval on August 1, Jardiance (empagliflozin) is now commercially available in the US by prescription at major pharmacies for people with type 2 diabetes. The launch makes Boehringer Ingelheim (BI)/ Eli Lilly’s Jardiance the third SGLT-2 inhibitor available in the US after Janssen’s Invokana and AstraZeneca’s Farxiga. After receiving European approval back in May 2014, Jardiance has already begun a European launch - available in both the UK and Germany.

The SGLT-2 inhibitor Jardiance comes as an oral, once-daily tablet, to be taken in addition to diet and exercise for adults with type 2 diabetes. This class of drugs causes the kidneys to excrete excess glucose through the urine, which lowers A1c and can even cause weight loss and improvements in blood pressure. As with other SGLT-2 inhibitors, Jardiance’s main side effects include genital tract infections (6% of people with type 2 diabetes on Jardiance developed a genital infection, compared to 2% of those on placebo), though they are manageable in most cases. While Jardiance is only approved for type 2 diabetes, some health care providers already use SGLT-2 inhibitors off-label for type 1 diabetes, and some trials are looking more closely at its effects in type 1. In some data we’ve seen, SGLT-2 inhibitors have allowed people with type 1 to spend more time in an ideal glucose range (less hypoglycemia and hyperglycemia) while taking less insulin.

BI/Lilly are offering a Jardiance Simple Savings program that offers eligible patients with insurance one year of free access to Jardiance – this program is similar to those for both Invokana and Farxiga, which also have year-long savings programs. Without insurance, out-of-pocket costs for 30 pills (a one month supply) of the 10 mg or 25 mg doses of Jardiance are $359.99 and $361.99 (respectively) at a local Walgreens.

Compared to Invokona and Farxiga, Jardiance may be the most accessible for people with impaired kidney function. People with eGFRs (a measure of kidney function, with lower numbers indicating worse function) down to 45 ml/min/1.73 m2 can use both doses of Jardiance (10 mg or 25 mg). In contrast, people with moderate kidney damage (eGFR between 45 and 60 ml/min/1.73 m2) are required to take the lower dose of Invokana, and Farxiga is not recommended at any dose.

Down the road, companies are looking at combining SGLT-2 inhibitors with other type 2 diabetes medications in a single pill. The fixed-dose combination (FDC) of Jardiance and Tradjenta (linagliptin, a DPP-4 inhibitor) is currently under FDA review, with a decision expected as early as February 2015. BI/Lilly’s Jardiance/Tradjenta FDC is the first in its class to be reviewed by the FDA, and if approved, would represent the first SGLT-2/DPP-4 inhibitor available to patients in the US. -AJW