Johnson & Johnson (JNJ) published positive results from a Phase 3 trial of its drug INVOKANA for the treatment of type 2 diabetes (T2D). In particular, it has been shown that the drug can reduce the risk of kidney failure in these patients with T2D. The company has already submitted a supplementary application for a new drug (sNDA) to the FDA for approval for this indication. I believe that with the positive clinical outcome, the company should be able to easily obtain FDA approval for INVOKANA in addition to the remarkable safety profile.
Phase 3 Data
The SNDA of INVOKANA was made possible thanks to a very positive phase 3. Results. The Phase 3 trial was known as CREDENCE and recruited 4,401
Believe it or not, T2D, however, is the leading cause of kidney failure for millions of people worldwide. How does someone with T2D suffer from kidney damage? This is because these patients are at risk of damaging small blood vessels. In return, the kidney can not sufficiently cleanse the blood. The problem with this is that your body retains more salt and water, which can lead to weight gain and swelling of the ankle. In addition, waste accumulates in your blood, causing it to become poisonous. In the Phase 3 study, it should be noted that patients continued to receive the standard of care (SOC). Therefore, INVOKANA was given to this patient in addition to the SOC. INVOKANA has been 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.
This was a successful outcome, but there were other positive data to consider. INVOKANA reduced the risk of ESKD by 32%. Why is this data so important to these patients? Because it was the first drug in nearly 20 years to reduce the risk of kidney failure. INVOKANA also reduced the risk of multiple cardiovascular outcomes. The sNDA for INVOKANA in T2D patients with chronic kidney disease was submitted in March 2019.
Johnson & Johnson needed this kind of strong data for INVOKANA. This is because sales lagged some competitors, especially those who also developed SGLT2 inhibitors. JNJ found that INVOKANA sales fell to $ 881 million in 2018 . Compared to 2016, the drug generated sales of 1.4 billion US dollars. Hopefully, this new benefit for INVOKANA will improve sales in the T2D segment. JNJ still has to fight 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 revenue of $ 1.4 billion in 2018. Eli Lilly and his partner with Jardiance had sales of $ 658.3 million in 2018. I am convinced that INVOKANA can shine with the latest Phase 3 data. It can help T2D patients reduce the risk of end stage kidney disease.
The recent positive results of the treatment of T2D with INVOKANA are highly suitable for Johnson & Johnson. The late-stage study showed that patients taking the drug were able to reduce the risk of ESKD by 32%. As mentioned earlier, T2D is the leading cause of kidney failure. If such a drug can even reduce the risk of kidney failure many times over, it will certainly be a sought after treatment. The first risk is that there is no guarantee that the FDA will approve the drug. This means that a possible approval can be delayed by one year or more. The second risk concerns the above-mentioned competitors. There are several competitors in the same room, who also generate high sales of their diabetes medications. It will not be easy to overcome that, but the recent finding that INVOKANA reduces the likelihood of ESKD should definitely help Johnson & Johnson.
This article is published by Terry Chrisomalis, who operates the pharmaceutical service of Biotech Analysis Central on Seeking Alpha Marketplace. If you like and subscribe to what you read here, I currently offer a two-week free trial period for subscribers. My service provides a deep dive analysis of many pharmaceutical companies. The marketplace of Biotech Analysis Central SA costs US $ 49 per month, but those who sign up for the annual plan can claim a discount price of 33.50% to US $ 399 per year.
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