FDA advisory committee votes down approval of Boehringer and Lilly’s drug for type 1 diabetes

pharmafile | November 14, 2019 | News story | Sales and Marketing Boehringer Ingelheim, Eli Lilly, empagliflozin, jardiance, pharma 

Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), after the independent panel voted against the use of the pair’s SGLT2 inhibitor empagliflozin (branded as Jardiance) as an add-on insulin therapy in the treatment of type 1 diabetes.

The drug is already approved, with the FDA passing approval in 2014 for the reduction of blood sugar levels in type 2 diabetes patients. However, the US regulator’s panel voted 14-2 against the notion of this latest approval, based on concerns that the available data could not demonstrate that therapy’s efficacy outweighed its risks to patients.

Specifically, the panel’s concerns balanced on the increased risk of diabetic ketoacidosis (DKA) associated with the drug’s use, and indeed all SGLT2 inhibitors. The complication is caused when ketone acids build up in the body when fat is burned instead of glucose for energy, and can be life-threatening.

As a result of the concerns, the panel advised that at least one further study with a larger sample size will be necessary in order to accurately determine these risks.

The FDA is not bound to the panel’s decision, but the regulator’s own decisions traditionally tend to mirror that of its advisory committees.

Lilly commented: “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.”

Matt Fellows

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