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FDA advisors say no to empagliflozin in type 1 diabetes

Approval of Boehringer, Lilly-partnered drug expansion looks unlikely

Boehringer/Lilly

Boehringer Ingelheim and Eli Lilly’s hopes of expanding the use of their empagliflozin drug into type 1 diabetes look out of reach for the time being, after an FDA advisory committee voted 14-2 against approval.

The panel said that the data on a 2.5mg dose of the SGLT2 inhibitor – already approved for type 2 diabetes at a higher dose under the trade name Jardiance – suggested that the risks didn’t outweigh the benefits of using the drug as an add-on to insulin in patients who struggle to control blood sugar using insulin alone.

The main concern was empagliflozin’s safety, and specifically the risk of diabetic ketoacidosis (DKA), a side effect that in severe cases can lead to kidney damage, respiratory failure and death.

The data for the marketing application comes from the EASE phase 3 trial programme, which found that empagliflozin at 2.5 mg in combination with insulin provided a statistically significant reduction in haemoglobin A1C – a marker for glucose control – compared to insulin plus placebo.

Some panellists said the size of the trial and its relatively short duration made it hard to be confident about the drug’s risk-to-benefit profile.

One advisor who voted against approval – Thomas Weber of Duke University Medical Centre – said that the data for Jardiance was promising however and another trial to establish the safety and efficacy, over at least two years, could sway his opinion.

The FDA isn’t bound by its advisors’ decision, but is considered likely to follow it given the proportion of panellists who voted Jardiance down. That means Boehringer and Lilly now have to decide whether approval in type 1 diabetes is worth the cost of running another trial.

If they do eventually get approval the intention is to sell the drug for type 1 diabetes under a separate brand name.

Empagliflozin isn’t the first SGLT2 inhibitor that has tried and failed to get a recommendation in type 1 diabetes past the FDA’s advisors because of the risk of DKA.

Earlier this year the panel was split on whether they should back approval of Lexicon Pharma’s Zynquista (sotagliflozin) as an insulin adjunct in these patients, and the FDA’s subsequent rejection of the indication prompted Sanofi to exit its alliance with Lexicon on the drug.

Meanwhile, in July the FDA also turned down AstraZeneca’s filing for its SGLT2 drug Farxiga (dapagliflozin) in type 1 diabetes, although the drug has been approved in this indication in Europe as well as Japan.

Lilly’s head of product development, Jeff Emmick, said that the company is committed to improving treatment options for type 1 diabetes, “as less than a third of…patients in the US consistently meet target blood sugar levels with insulin, putting them at increased risk for long-term complications”.

At the moment the only drug approved as an adjunct to insulin to improve glucose control is AstraZeneca’s Symlin (pramlintide), an injectable given alongside mealtime insulin therapy. SGLT2 inhibitors could provide an oral alternative, if approved.

Article by
Phil Taylor

14th November 2019

From: Regulatory

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