Lilly/BI launch Jardiance (empagliflozin) in the US – August 27, 2014

Lilly and BI just announced that their partnered SGLT-2 inhibitor Jardiance (empagliflozin) is now available to patients in US pharmacies, making it the third SGLT-2 inhibitor launched in the US behind J&J’s Invokana (canagliflozin) and AZ’s Farxiga (dapagliflozin). We are impressed by Lilly/BI’s rapid turnaround time between Jardiance’s FDA approval on August 1 and its launch. Jardiance was also recently approved by the EMA, with a European launch expected in 3Q14 starting with the UK and Germany (according to Lilly’s 2Q14 update). In the US, Lilly and BI are offering a Simple Savings copay assistance program, which offers eligible patients with commercial insurance free access to Jardiance for at least one year; yearlong patient assistance programs are available for Invokana and Farxiga as well. As we saw from the FDA’s approved prescribing information for Jardiance, patients with eGFRs down to 45 ml/min/1.73 m2 can use either dose of Jardiance. In contrast, with Invokana, patients with eGFRs between 45 and 60 ml/min/1.73 m2 are limited to the lower 100 mg dose, while Farxiga is completely contraindicated in patients with eGFRs below 30 ml/min/1.73 m2, and not recommended in patients with eGFRs between 30 and 60 ml/min/1.73m2. In addition to the completion of the EMPA-REG OUTCOME CVOT slated to end early next year, the FDA is requiring three postmarketing studies: (i) a pediatric PK/PD study; (ii) a pediatric safety study; and (iii) a nonclinical juvenile toxicity study. In our view, perhaps the most promising use for empagliflozin will be through a fixed-dose combination with the DPP-4 inhibitor Tradjenta (linagliptin); the FDA accepted the NDA for empagliflozin/linagliptin in April, and we saw promising phase 3 data presented on the combination at ADA.