AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line.
The FDA on Tuesday approved Farxiga to reduce the risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction (HFrEF) and with or without Type 2 diabetes, AstraZeneca said, a first in the SGLT2 class of diabetes drugs.
Farxiga is now cleared to treat roughly six million U.S. HFrEF patients each year, expanding on its earlier FDA approvals to treat heart failure patients with Type 2 diabetes and to improve glycemic control in Type 2 diabetes patients.
Farxiga's newest approval followed an FDA priority review granted in January and a fast-track designation in September. The drug has also received fast-track reviews in heart failure with a preserved ejection fraction (HFpEF)––an indication with no approved therapies––and chronic kidney disease (CKD).
The FDA based its review on data from the phase 3 Dapa-HF trial, which showed Farxiga cut CV risks by 26% over standard of care in patients with and without diabetes.
AstraZeneca will leverage its "strong position and legacy" in the cardiovascular and metabolic markets and an already fleshed-out commercial team to help support Farxiga's launch, said Kiersten Combs, AstraZeneca's VP of cardiovascular and metabolic disease.
"We have a team in place across all of those specialties ready to go and ready to bring this new indication and this broader strategy to market almost immediately," Combs said.
AstraZeneca has moved to a virtual sales model with the novel coronavirus pandemic continuing to rage, and Combs indicated the launch could be slower than normal given physicians' focus on COVID-19.
"We will engage and bring this information to (physicians) as appropriate across our specialty groups, and as things start to ease up we will turn to more face-to-face interactions, whatever that will look like," she said. "As we see people who are contracting COVID-19, we see that keeping patients out of the hospital is important, and that's something Farxiga can offer patients with heart failure."
As the first to market, AstraZeneca will make a "significant investment" in physician education through peer-to-peer and scientific engagement, Combs said. The drugmaker will also take a two-pronged approach to educating patients, with direct-to-consumer advertising as well as non-branded education campaigns.
Farxiga's approval may be a boon not only for AstraZeneca but also for its SGLT2 competitors, including Boehringer Ingelheim and Eli Lilly's Jardiance and Johnson & Johnson's Invokana.
The possible "class effect" of Farxiga's new indication could lead to future competition, Combs admitted, but AstraZeneca will lean on the drug's promising pipeline to stay competitive.
"Whether it's class effect or not, all I can say is that the scientific evidence that Farxiga is generating is quite promising and very meaningful," Combs said.
In late March, AstraZeneca halted its phase 3 Dapa-CKD trial evaluating Farxiga in chronic kidney disease after interim data "showed Farxiga's benefits earlier than originally anticipated." The primary endpoint of Dapa-CKD was a composite of kidney function worsening or death in patients with or without Type 2 diabetes, AstraZeneca said.
Chronic kidney disease is the ninth-leading cause of death in the U.S. and affects around 30 million Americans each year.
Meanwhile, AstraZeneca is pursuing HFpEF in two separate trials––Deliver and Determine––and has already received an FDA fast track in that indication. In all, AstraZeneca is evaluating Farxiga in 35 completed and ongoing trials, with more than 35,000 patients enrolled so far.