https://issuesinsights.com/2022/07/01/the-fda-is-blocking-game-changing-new-drugs-for-kidney-disease/
Imagine you’ve been diagnosed with chronic kidney disease, told by your physician that if it can’t be managed, you may eventually need a transplant or long-term dialysis. This scary situation is one faced by hundreds of thousands of Americans every year.
Chronic kidney disease (CKD) is an illness that affects an estimated 37 million people in the U.S. That’s more than one in seven adults across the country, or nearly the entire population of California. Despite this alarming statistic, investment in kidney disease research and therapies lags other sectors. We must redress that imbalance.
CKD is a serious condition that, if unaddressed, leads to organ failure. Without early interventions and disease management, CKD leads to an increased chance of heart disease, stroke, vascular disease, and even early death. Another serious, common complication – renal anemia – can cause debilitating symptoms that severely impact patients’ quality of life. Physicians and the millions of Americans living with CKD need more, and better, treatment options.
While there have been increased efforts toward innovation in the kidney care community to provide new, effective treatments for patients, the U.S. Food and Drug Administration (FDA) has rejected most of the drugs for kidney disease that it has reviewed in recent years. Perhaps for that reason, nephrology has historically had one of the lowest rates of new drug applications submitted to the FDA, particularly when compared to other therapeutic areas like oncology and cardiology.
Although the Department of Health and Human Services (HHS) has championed advancements in kidney care through initiatives like the public-private Kidney Innovation Accelerator (KidneyX), the FDA seems not to be onboard. By failing to approve drugs to treat patients with CKD and renal anemia, the FDA is out of step with the administration’s efforts to advance the development and access to cutting-edge treatments that have the potential to greatly improve patients’ lives and appear to have demonstrated a favorable risk-benefit profile.
The development of new kidney drugs such as vadadustat, one of a class of drugs called HIF-PHI, has given hope to the community that more options will be available to patients. Like other drugs in this new trailblazing class, it works by using the body’s innate oxygen sensing mechanism to stimulate red blood cell production, a great help to patients with anemia due to CKD.