AstraZeneca is on its way to scoring a key new nod for SGLT2 diabetes drug Farxiga, and the FDA just sped things up.
The agency doled out its fast track designation to Farxiga in chronic kidney disease patients after a study showed it could stave off kidney failure and prevent cardiovascular or kidney-related death. The move sets Farxiga up to score an indication in a disease that affects an estimated 200 million people around the world—and one no other SGLT2 inhibitor is currently approved to treat.
Presented in June at the American Diabetes Association annual meeting, the data showed Farxiga could pare down the combined risk of kidney function decline, end-stage renal disease and renal death in Type 2 diabetes patients by 47%. The British drugmaker is also running a separate phase 3 trial, called Dapa-CKD, examining Farxiga’s effects on kidney outcomes and cardiovascular death in kidney disease patients with and without Type 2 diabetes.
AstraZeneca won't necessarily be peerless in the CKD field by the time its potential approval rolls around, though. Competition from Johnson & Johnson, which markets nemesis Invokana, is coming up fast. In May, U.S. regulators granted that drug a priority view in patients with diabetes and chronic kidney disease based on an outcomes trial showing Invokana could cut disease and death risks.
Of course, that indication doesn’t mirror the one Farxiga is chasing; if approved, AZ’s drug would be eligible for CKD patients without diabetes, where Invokana would not. And that niche is important to Farxiga, which is playing behind Invokana and Boehringer Ingelheim and Eli Lilly’s Jardiance in another arena: Both of those rivals bear heart-helping indications based on positive cardiovascular outcomes data.
AstraZeneca’s current lack of a cardiovascular nod for Farxiga hasn’t stopped it from growing sales by 14% in the first half of 2019. Over the first six months of the year, it raked in $726 million around the world to rank as the company’s fifth-best-selling product over that span.
And the pharma giant only expects those numbers to jump once it does score a CV green light, an event it’s expecting later this year.
Meanwhile, the priority review marks the second good piece of Farxiga news AZ has received in the past week. Last Tuesday, new outcomes data showed Farxiga could pare down cardiovascular risks in heart failure patients with or without diabetes.