No surprise: After near unanimous adcomm, FDA rejects Eli Lilly bid to bring Jardiance to type 1 patients
In an unsurprising move, the FDA has rebuffed Eli Lilly and Boehringer Ingelheim in their efforts to expand the indication for their best-selling diabetes drug Jardiance, issuing a complete response letter.
The CRL came four months after an FDA advisory committee voted 14-2 against allowing the two drugmakers to market the drug for type 1 diabetes, saying the risks outweighed the potential benefits. The FDA does not publicly release its rejection letters, but in a press release, Eli Lilly acknowledged the ruling was “consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee in November.”
That committee ruled Lilly and Boehringer would need to conduct another study to better assess safety, opening the door for an eventual resubmission. Neither Lilly nor Boehringer, which originally developed the compound, commented in their joint release on whether they would pursue.
Jardiance belongs to a class of drugs known as SGLT-2 inhibitors. These drugs, first introduced in the US by J&J in 2013, inhibit a protein in the kidneys that controls how the organs reabsorb glucose. If you inhibit the protein, you can lower glucose reabsorption and thus lower blood sugar levels. Jardiance was approved in 2014 and indicated, like other SGLT-2 inhibitors, for type 2 diabetes.
With type 2 diabetes becoming one of the most common chronic illnesses across much of the planet, the drugs have reaped billions for J&J, AstraZeneca, Lilly and Novo Nordisk, and precipitated efforts by each drugmaker to expand the list of potential patients. Lilly has come up short in the latest efforts; while AstraZeneca and Novo Nordisk won specialized approval for lowering the risk of cardiovascular events such as heart attacks, Lilly’s data for the same indications underwhelmed.
The NJ-based legacy pharma is now the third company to try and fail to win US approval for their SGLT-2 inhibitor in type 1 patients, joining AstraZeneca and Sanofi. The agency has been wary because of data suggesting the drug can cause diabetic ketoacidosis, a life-threatening complication in which the body, short on insulin, switches to burning fats, letting off potentially toxic levels of acidic ketone bodies.
Type 2 patients can get diabetic ketoacidosis but it is far more prevalent in type 1 patients. Lilly’s proposed submission called for doses of 2.5mg and the drug would’ve been taken solely as an adjunct to insulin — a sharp dosing contrast to type 2 patients, who received 10 or 25 mg and take it with or without insulin. The FDA review in November noted Lilly showed Jardiance improved blood sugar levels in Type 1 patients but said their lone 26-week study didn’t adequately dispel concerns about adverse effects.