- Eli Lilly and Boehringer Ingelheim's diabetes drug Jardiance could have a second act in type 1 diabetes, proving effective as a complementary treatment to insulin in two Phase 3 studies of patients with the less common form of the chronic condition.
- Detailed results were not disclosed but Eli Lilly said Monday all three tested doses of Jardiance, which is approved in the U.S. to lower blood sugar in adults with type 2 diabetes, met the the primary efficacy goal for A1C lowering after 26 weeks of treatment.
- Jardiance's safety profile appeared consistent with results from prior studies, the drugmaker said, although higher doses of the SGLT-2 inhibitor led to more adjudicated cases of diabetic ketoacidosis than did placebo.
Compared to advances in treating type 2 diabetes, there have been fewer new medicines for the type 1 form of the condition, which affects an estimated 1.3 million people in the U.S.
"Despite recent advances in insulin therapy and patient care, less than one third of adults with type 1 diabetes in the U.S. consistently meet target blood sugar levels," said Thomas Seck, head of clinical development and medical affairs for primary care at Boehringer Ingelheim.
Considered an autoimmune disease, type 1 diabetes necessitates daily injections of insulin for blood sugar regulation.
Lilly and Boehringer's studies of Jardiance (empagliflozin) explored whether adding it to insulin treatment could help with control of blood sugar levels versus placebo. Nearly 1,700 patients were enrolled into the two trials, called EASE-2 and EASE-3.
Both met their primary endpoint, meeting the goal for placebo-corrected change from baseline in A1C after 26 weeks of treatment. Full results won't be available, however, until October, during the annual meeting of the European Association for the Study of Diabetes.
As a treatment for type 2 diabetes, Jardiance has been gaining momentum commercially. Sales recorded by Lilly, which recognizes a share of the gross margin for the drug, totaled $151 million through the first three months of 2018 — more than double the amount from the same period a year ago.
Boehringer Ingelheim recorded 1.01 billion euros (about $1.2 billion) in product sales of Jardiance last year and claims the drug is the most frequent newly prescribed SGLT-2 inhibitor.
Among that drug class, Jardiance competes with AstraZeneca's Farxiga (dapagliflozin) and Johnson & Johnson's Invokana (canagliflozin). Data cited by Cowen, an investment firm, shows Jardiance has about a 40% share of new-to-brand prescriptions among the three drugs.
Jardiance's share has risen steadily, buoyed in part by an expanded indication from the Food and Drug Administration for efficacy in reducing the risk of cardiovascular events.
None of the three are currently approved for use in type 1 diabetes. Lilly said it and Boehringer Ingelheim are discussing "next steps and exploring regulatory options" for Jardiance in type 1.