FDA turns down label expansion for Jardiance as an adjunct to insulin in type 1 diabetes
pharmafile | March 23, 2020 | News story | Sales and Marketing | FDA, diabetes, jardiance, pharma
The FDA has chosen not to approve an expanded indication of 2.5mg Jardiance (empaglifozin) as an adjunct to insulin in the treatment of type 1 diabetes.
The decision follows a recommendation in November 2019 from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) not to approve the therapy. The committee voted 14-2 against, arguing that the 2.5mg dose did not present an adequate benefit/risk profile as an adjunct to insulin.
This was despite Phase 3 data showing that Jardiance combined with insulin significantly reduced A1C test scores, which indicate average blood sugar levels, compared to insulin and placebo.
The drug, developed by Eli Lilly and Boehringer Ingelheim, is already approved by the FDA for the treatment of type 2 diabetes and has been since August 2014. Two years later it secured an expanded indication from the US regulator for treating cardiovascular issues in type 2 diabetes patients.
“The challenges of managing blood sugar levels for those with type 1 diabetes, and the desire for new treatment options, reveal important unmet needs in the diabetes community,” remarked Mohamed Eid, Vice President, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine for Boehringer Ingelheim. “We remain committed to the continued study of Therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes.”
He added: “With about 40,000 Americans diagnosed with type 1 diabetes every year, we see today’s meeting as an important means of elevating the discussion around the challenges of managing blood sugar levels for those with type 1 diabetes and the need for new treatment options. We continue to believe the totality of data from the EASE programme indicates a favourable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continue to work with the FDA in this review process.”
Matt Fellows
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