Johnson & Johnson announced that it had achieved positive results in a phase 3 study using INVOKANA along with standard of care to treat type 2 diabetes patients.

The most notable finding from the study is that INVOKANA was shown to be able to reduce the risk of end-stage kidney disease for these type 2 diabetes patients by 32%.

The company has already submitted its sNDA for INVOKANA to treat patients with type 2 diabetes who have kidney disease.

INVOKANA is the first medicine in nearly 20 years to be able to show the ability to reduce progression to renal failure in this patient population.

Johnson & Johnson (JNJ) released positive results from a phase 3 study using its drug INVOKANA to treat patients with type 2 diabetes (T2D). Specifically, it showed that the drug could reduce the risk of renal failure for these patients with T2D. The company has already submitted a supplemental new drug application (sNDA) to the FDA for approval for this indication. I believe with the positive clinical outcome, in addition to the remarkable safety profile, the company should easily be able to gain FDA approval for INVOKANA.

Phase 3 Data

The sNDA of INVOKANA was made possible thanks to highly positive phase 3 results. The phase 3 study was known as CREDENCE, and it recruited 4,401 patients with T2D who also had stage 2 or 3 chronic kidney disease (CKD). This study was evaluated using a composite endpoint. A composite endpoint is multiple clinical endpoints that lead to the most important findings from the study. The primary measures of the composite endpoint were: end-stage kidney disease (ESKD), renal or cardiovascular (CV) death, and doubling of serum creatinine. In terms of serum creatinine, that means attempting to keep the level of that in the normal range. For instance, if a patient has an abnormal level of creatinine, that means they have significant kidney damage. Other secondary endpoints looked at cardiovascular health. That can be broken down into cardiovascular death and congestive heart failure. All these endpoints were established for this study because patients with T2D are at significant risk for these events. – Seeking Alpha