Almost a year after receiving groundbreaking approval for heart failure patients with or without type 2 diabetes, Farxiga received another notable OK from AstraZeneca on Friday.
The SGLT2 inhibitor received the go-ahead from the FDA for chronic kidney disease in adults at risk of progression, the UK pharmaceutical industry said late Friday afternoon. Similar to the heart failure admission, the gain will also be displayed on Friday for patients, regardless of whether they have type 2 diabetes. Farxiga was originally approved for the treatment of type 2 diabetes in 2014.
I pangalos
The drug is now the first in its class to treat CRF regardless of diabetes status. A move that R&D boss Mene Pangalos described in a statement as “the most significant advance in the treatment of chronic kidney disease in more than 20 years”.
Farxiga has proven to be one of AstraZeneca’s biggest sellers, growing 30% over the past year when sales were nearly $ 2 billion. Although Farxiga came out after J&J rival Invokana, it managed to consume a large portion of the SGLT2 cake after Invokana was hit with a black box warning of increased amputation risk.
With the extended label, Farxiga is also well ahead of Eli Lilly and Boehringer Ingelheim’s competitor Jardiance, who will probably read the CKD data out aloud next year at the earliest.
AstraZeneca had been adding to the excitement about the drug since they completed their CKD study in early March 2020 when they claimed to have “overwhelming effectiveness”. They followed with data in August showing that Farxiga reduced cardiovascular or renal mortality and deterioration in renal function by 39% compared to placebo. Farxiga also reduced the risk of death for some reason by 31%.
The dataset proved impressive enough to earn the FDA’s breakthrough therapy designation in October and priority review in January. And exploratory analysis from one of its Phase III studies reportedly showed the drug may be effective in CKD patients with less severe medical conditions, the UK drug maker said.
The approval on Friday will open Farxiga to a market of approximately 37 million patients in the US, AstraZeneca says.
Although the pharmaceutical industry has anchored a trend reversal, especially in its oncology portfolio, CEO Pascal Soriot has long set himself the goal of expanding Farxiga from diabetes to other diseases. That ambition has largely proven successful over the past two years, first with heart failure clearance and now with Friday’s CKD win.
Farxiga, like its compatriots, acts with SGLT2 inhibitors on a protein in the kidneys that affects the reabsorption of glucose by the body. By blocking the SGLT2 protein, the drugs reduce reabsorption and, consequently, blood sugar levels.
The full indication for CRF allows the use of Farxiga to reduce the risk of persistent decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease (ESKD), cardiovascular death (CV), and hospitalization for heart failure (HF) in adults with the disease.
