The decision follows an FDA panel vote last November recommending against the approval of the drug.
Eli Lilly and Boehringer Ingelheim have received a complete response letter from the US Food and Drug Administration (FDA) regarding the filing of Jardiance (empagliflozin) as an adjunct to insulin for adult patients with type I diabetes.
The company says that the decision follows an FDA panel vote last November recommending against the approval of the drug, where the organisation cited the need for an additional study in order to assess safety risks for the SGLT-2 inhibitor.
The response letter indicates that the FDA is unable to approve the companies’ supplemental New Drug Application (sNDA) in its current form.
“The challenges of managing blood sugar levels for those with type I diabetes, and the desire for new treatment options, reveal important unmet needs in the diabetes community,” said Mohamed Eid, vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim.
He continued, ”We remain committed to the continued study of therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes.”
Eli Lilly reminds that approximately 34.2 million Americans and an estimated 463 million adults worldwide have type I and type II diabetes, with type II being the most common form and accounting for an estimated 90% to 95% of all diagnosed adult diabetes cases in the US.
Just last week the FDA granted Boehringer Ingelheim Fast Track designation for the investigation of Jardiance in reducing the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.