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Johnson & Johnson (JNJ) has published positive results from a phase 3 study using its drug INVOKANA treat patients with type 2 diabetes (T2DM). Specifically, he showed that the drug could reduce the risk of kidney failure in these patients with T2DM. The company has already submitted an additional new drug application (sNDA) to the FDA for approval for this indication. I believe that with the positive clinical outcome, in addition to the outstanding safety profile, the company should easily be able to obtain FDA approval for INVOKANA.
Phase 3 data
INVOKANA sNDA was made possible thanks to the very positive results of phase 3. The phase 3 study was known as CREDENCEand he recruited 4,401 patients with T2DM who also had stage 2 or 3 chronic renal failure. This study was evaluated using a composite endpoint. A composite endpoint consists of several clinical endpoints that lead to the main findings of the study. The main measures of the composite endpoint were: end-stage renal failure (ESR), renal or cardiovascular (CV) death, and serum creatinine doubling. In terms of serum creatinine, this means trying to maintain the level of serum creatinine in the normal range. For example, if a patient has an abnormal creatinine level, it means that he has significant kidney damage. Other secondary endpoints have focused on cardiovascular health. This can be broken down into cardiovascular death and congestive heart failure. All of these assessment criteria were established for this study because patients with T2DM are at significant risk for these events.
Believe it or not, but T2D is the leading cause of kidney failure for millions of people around the world. How does a person with T2D have kidney damage? This is because these patients run the risk of damaging small blood vessels. In turn, the kidney is not able to clean the blood enough. The problem is that your body retains more salt and water, which can lead to weight gain and swelling of the ankle. In addition to this, the waste accumulates in your blood, making it toxic. One thing to note about the Phase 3 study is that patients continued to follow Standard Treatment (SOC). Therefore, INVOKANA has been administered to these patients in addition to SOC. INVOKANA has been shown to reduce the risk associated with the composite primary endpoint for these patients by 30%. This was done with a statistically significant p value of p <0.0001.
This was a success, but there was another positive data to consider. INVOKANA was able to reduce the risk of MPS by 32%. Why is this data very important for these patients? Indeed, it was the first drug for nearly 20 years to reduce the risk of kidney failure. INVOKANA has also been able to reduce the risk of several cardiovascular parameters. SNDA for INVOKANA in patients with T2DM and chronic kidney disease was submitted in March 2019.
The competitors
Johnson & Johnson really needed this kind of solid data for INVOKANA. Indeed, its sales have lagged behind a few competitors, especially those who have also developed drugs that inhibit SGLT2. JNJ noted that INVOKANA sales dropped in 2018 to reach $ 881 million. This compared to 2016, when the drug had generated sales of $ 1.4 billion. Hope this new benefit for INVOKANA will improve sales in the T2D space. JNJ has yet to face 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 a turnover of $ 1.4 billion for the year 2018. Eli Lilly and her partner with Jardiance have achieved a turnover of 658, $ 3 million for the 2018 fiscal year. I believe that INVOKANA can begin to shine with its latest phase 3 data. It will be able to help T2D patients reduce the risk of develop end stage renal disease.
Conclusion
The latest positive results with INVOKANA in treating patients with T2DM are very ideal for Johnson & Johnson. The advanced study showed that patients taking this medication were able to reduce the risk of getting KST by 32%. As I noted above, T2D is the leading cause of kidney failure. If such a drug can reduce the risk of infection of kidney failure, it will certainly be a treatment sought. The first risk is that there is no guarantee that the FDA approves the drug. This means that potential approval could be delayed for a year or more. The second risk concerns the competitors mentioned above. In the same space, several competitors also made big sales for their diabetes medications. It will not be easy to overcome, but INVOKANA's latest findings, which reduce the risk of contracting an ESKD, should certainly help Johnson & Johnson.
This article is published by Terry Chrisomalis, who heads the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and want to subscribe to a subscription, I currently offer a free two week trial period to subscribers. My service offers in-depth analysis of many pharmaceutical companies. The market for Biotech Analysis Central SA is $ 49 per month, but for those who sign up for the annual plan, they will enjoy a discount of 399% per year at a price of 33.50%.
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