FDA bats back AstraZeneca's SGLT diabetes drug for Type 1 diabetes — blocking a class on safety fears
The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.
The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.
Sanofi and Lexicon went to the FDA with their application for Zynquista (sotagliflozin) in Type 1 and were batted back a few months ago after an advisory committee split down the middle, with warnings about a higher rate of diabetic ketoacidosis (DKA) in the SGLT arm. That’s a condition that can be hard to spot for this indication, raising the chances of hospitalization for patients who are unaware that they urgently need to take insulin and consumer carbs.
And that’s a threat that the FDA clearly believes applies across the class, despite assurances of a safety program aimed at constantly assessing ketone levels, which flag DKA.
AstraZeneca has enjoyed rapidly rising sales for this new diabetes franchise, grabbing $1.4 billion in growing 2018 sales. Its regulatory issue is also apparently restricted to the FDA and the all-important US market. Europe approved this drug for Type 1 diabetes in March, with the EMA satisfied by the evidence of weight loss A1c control along with lower insulin use.
The drug is designed to spur the elimination of glucose in urine.
Image: AstraZeneca, AP