FDA Grants Breakthrough Therapy Designation for Chronic Kidney Disease Treatment

The FDA has recently granted the Breakthrough Therapy designation to FARXIGA, a chronic kidney disease treatment created by AstraZeneca. This designation will allow for a quicker development, which will hopefully allow for this medication to help patients sooner.

About Chronic Kidney Disease (CKD)

Chronic kidney disease (CKD) occurs when there is damage in the kidneys that progresses over time. About 26 million adults in the United States are affected by CKD. It is often the result of another condition, such as diabetes, high blood pressure, and polycystic kidney disease among others. Patients will experience the symptoms of their first disorder along with the effects of CKD, which include jaundice, stunted growth, high blood pressure, an enlarged liver or spleen, nausea, lack of appetite, vitamin deficiencies, fatigue, sleep issues, weakness, muscle cramps and twitches, changes in urination, persistent itching, shortness of breath, and swelling in the feet and ankles. Treatment is symptomatic and focuses on reducing complications and slowing progression. Doctors may prescribe diuretics, high blood pressure medication, cholesterol medication, anemia medication, and supplements to protect the bones. If CKD progresses enough, dialysis and kidney transplants may be necessary.

Breakthrough Therapy Designation

The Breakthrough Therapy designation is intended to speed up the development process, as well as regulatory review. It is reserved for treatments for serious conditions with unmet medical needs. In order to receive this designation, early trial results have to be promising. There must also be a substantial improvement over existing treatments.

In FARXIGA’s case, the DAPA-CKD trial earned it the designation. This study proved that FARXIGA performs better than the standard of care in terms of renal function and risk of cardiovascular and renal death. When compared to a placebo, this medication performed 39% better. It also reduced death from any cause by 31%. These results led the FDA to grant the Breakthrough Therapy designation.

To find out more about FARXIGA click here.

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