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.
Believe it or not, but T2D is the leading cause of kidney failure for millions of people worldwide. How does someone with T2D exactly suffer from kidney damage? That’s because those patients are at the risk of small blood vessels becoming damaged. In turn, the kidney is not able to sufficiently clean the blood. The problem with that is your body retains more salt and water, which may lead to weight gain and ankle swelling. On top of that, waste materials build up in your blood, causing it to become toxic. One thing to note about the phase 3 study is that patients continued to take standard of care (SOC). Therefore, INVOKANA was given to these patients on top of SOC. INVOKANA was shown to reduce the primary composite endpoint risk for these patients by 30%. This was achieved with a statistically significant p-value of p<0.0001.
That was a successful outcome, but there was another piece of positive data to consider. INVOKANA was able to reduce the risk of ESKD by 32%. Why is this piece of data very important for these patients? That’s because it was the first drug in nearly 20 years to reduce the risk of renal failure. INVOKANA was also able to reduce the risk of multiple cardiovascular endpoints. The sNDA for INVOKANA in T2D patients with chronic kidney disease was submitted back in March 2019.
Johnson & Johnson really needed this type of strong data for INVOKANA. That’s because it has been lagging behind in sales compared to a few competitors, especially those who have also developed SGLT2 inhibitor drugs. JNJ noted that INVOKANA sales dipped in 2018 to $881 million. This compared to 2016, where the drug generated $1.4 billion in sales. Hopefully, this newfound advantage for INVOKANA will lead to improved sales in the T2D space. JNJ still has to go against several competitors. These competitors are AstraZeneca (AZN) with Farxiga and Boehringer Ingelheim and Eli Lilly (LLY) with Jardiance. AstraZeneca is doing very well with Farxiga, generating full-year 2018 sales of $1.4 billion. Eli Lilly and its partner with Jardiance produced full-year 2018 sales of $658.3 million. I believe that INVOKANA can start to shine with its latest phase 3 data. It will be able to help T2D patients reduce the risk of obtaining end-stage kidney disease.
The latest positive results using INVOKANA to treat patients with T2D is highly ideal for Johnson & Johnson. The late-stage study showed that patients taking the drug were able to reduce the risk of obtaining ESKD by 32%. As I noted above, T2D is the leading cause of kidney failure. If such a drug can reduce the risk of someone advancing to kidney failure even by that much, it will be a sought-out treatment for sure. The first risk is that there is no guarantee that the FDA will approve the drug. That means potential approval could be delayed for a year or more. The second risk involves the competitors noted above. There are several competitors in the same space that have been achieving high amounts of sales for their diabetes drugs as well. It won’t be easy to overcome that, but the latest finding of INVOKANA reducing the chance of ESKD should definitely help Johnson & Johnson.
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