Janssen's INVOKANA (canagliflozin) Gets Boost Over Competitors with FDA Approval for Diabetic Kidney Disease and a Newly Minted Collaboration with Renal Giant, Vifor Pharma

EXTON, Pa., Nov. 25, 2019 /PRNewswire/ -- It is well-documented that nearly half of patients with type 2 diabetes will eventually develop diabetic kidney disease (DKD), which is the most common cause of kidney failure in the United States. INVOKANA, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is the first agent shown to slow the progression of DKD since the standard of care (angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers) was introduced nearly 20 years ago. INVOKANA was initially approved for the treatment of type 2 diabetes in March 2013 and thus has amassed significant post-marketing data. Following the FDA approval on September 30, 2019, Janssen entered into a commercial collaboration with Vifor Pharma on November 4^th to promote the new indication to nephrologists. Presently, Vifor Pharma has an active renal sales force promoting VELTASSA (patiromer FOS) for hyperkalemia.

Spherix has been following trends in the nephrology market on a quarterly basis since mid-2015, and surveyed nephrologists consistently cite the high unmet need for new treatments for DKD. In fact, just prior to approval, a survey of 200 nephrologists conducted between August 27 and September 6, 2019 (RealTime Dynamix™: Renal Anemia, Q3 2019) found that 30% viewed INVOKANA as the pipeline agent they would most like to see win FDA approval. By comparison, 19% selected one of the HIF-PH inhibitors (roxadustat from AstraZeneca/Astellas/FibroGen, vadadustat from Akebia Therapeutics/Otsuka/Mitsubishi Tanabe, and daprodustat from GSK) for renal anemia, 11% selected Bayer's finerenone (another DKD contender), and 11% gravitated to Ardelyx's tenapanor, a new mechanism agent for hyperphosphatemia.

Despite the excitement surrounding INVOKANA, the Vifor Pharma team can expect challenges in driving a paradigm shift in the treatment of DKD among nephrologists. In a new study published today, Market Dynamix™: Diabetic Kidney Disease, Spherix surveyed over 300 nephrologists, endocrinologists, cardiologists, and primary care physicians about the treatment of DKD, their reaction to the INVOKANA DKD approval, unmet needs for new treatment options in DKD, and feedback on several late stage DKD contenders including finerenone, Novartis' nidufexor, Reata's bardoxolone methyl, Ironwood's praliciguat, ChemoCentryx's CCX140/CCR2, and Gilead's selonsertib.

On the plus side, nephrologists are very aware of and impressed with the CREDENCE trial results in which INVOKANA cut the risk of renal failure or death by 30%. More than 40% of surveyed nephrologists reported that they have recently begun to prescribe more SGLT2 inhibitors, and 59% reported prescribing in the past month. However, compared to other specialists, nephrologists are also more likely to view the kidney effects as a class effect shared with other SGLT2 products such as AZ's FARXIGA (dapagliflozin), Lilly/Boehringer Ingelheim's JARDIANCE (empagliflozin), and Merck's STEGLATRO (ertugliflozin), though familiarity with the latter is low across all specialties. Furthermore, when asked about barriers to INVOKANA, in addition to the typical market access woes reported for all new renal agents, more than one-quarter of the nephrologists cited low familiarity, a lack of samples to initiate new patients, and the dynamic that "another physician is typically responsible" for initiating the product. By way of comparison, the majority of endocrinologists and primary care physicians are unlikely to see the SGLT2 inhibitors as interchangeable and largely report a preference for JARDIANCE. Endocrinologists also report market access issues as a barrier to INVOKANA, but more than one-third report their preference for JARDIANCE, the fact that DKD patients are well-controlled on "other" treatments, and concerns about risk of amputation with INVOKANA as other obstacles for the brand to overcome.

Even with a new approval in hand, 84% of the surveyed nephrologists still report a high unmet need for new treatments. Physician demand for hard outcomes in DKD clinical trials were reinforced in the survey feedback, and when queried about agents in the pipeline, nephrologists handed the most favorable estimates to bardoxolone. Endocrinologists gravitated to nidufexor, as did cardiologists who placed finerenone a close second. Primary care physicians were more varied in their preferences.

Spherix will be tracking the DKD launch of INVOKANA in a quarterly series, RealTime Dynamix™: Diabetic Kidney Disease, which will kick off in Q1 2020 and will follow promotion levels, messaging, trial rates, experience, and shifting treatment patterns for the SGLT2 inhibitors, in addition to perceptions about pipeline DKD assets and where they are likely to fit in the DKD treatment algorithm.

About Market Dynamix™
Market Dynamix™is an independent service that utilizes a combination of qualitative and quantitative market research to explore the future dynamics of evolving healthcare treatment paradigms. The qualitative analysis is fueled by interviews with nephrologists in the trenches. The quantitative portion leverages our proprietary network of specialists coupled with robust patient chart analysis for sizing the market and to understand current perceptions, gaps in product awareness, and unmet needs.

About RealTime Dynamix™
RealTime Dynamix™is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

For more information contact:
Jake B. Guinto, PhD, Cardio-Renal Insights Director
Email: jake.guinto@spherixglobalinsights.com
Phone: 484-879-4284

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SOURCE Spherix Global Insights