Johnson and Johnson’s Invokana (canagliflozin) received FDA approval on the March 29 for the treatment of type 2 diabetes. It is the first SGLT2 inhibitor to be approved by the FDA, which had previously rejected Bristol-Myers Squibb and AstraZeneca’s Forxiga (dapagliflozin) for approval in January last year (Forxiga was granted approval in the EU in November 2012).
Invokana’s marketing authorisation was based on data from nine clinical trials that together enrolled over 10,000 patients with type 2 diabetes. In these studies, the product showed a superior level of efficacy at a dose of 300mg when compared to Merck & Co.’s Januvia (sitagliptin), a product that most analysts consider to be its major branded competitor. Invokana also benefits from having a label that states that it reduces both blood pressure and body weight.
However, analyst consensus suggests that Invokana may struggle for commercial success against incumbent competition, such as Januvia, as a result of safety concerns. The most common side effects seen during clinical trials were vulvovaginal candidiasis and urinary tract infections, which occurred at a rate of 10 and 5 percent respectively.
While the diabetes market is relatively complex with several different drug classes all competing against one another, Inovkana’s success will not purely be determined by its product profile but also by any change of physician perceptions for other drug classes. Study data published in JAMA Internal Medicine in February showed that patients treated with GLP-1 mimetics had a two-fold increased risk of being hospitalised with acute pancreatitis. The impact of this study on prescribing practice is yet to be seen, but analysts believe that it could potentially give Johnson & Johnson a useful marketing angle.
Physician attitudes towards the side-effect profiles versus the efficacy of the various drugs available for the treatment of type 2 diabetes will be key to how well Invokana performs in the market. FirstWord’s Physician Views poll will ask US-based endocrinologists about their expected usage of Invokana.
Specifically the poll will ask:
• What impact will safety concerns regarding the GLP-1 and DPP-IV drug classes have on the use of Invokana
• Which products will physicians use Invokana instead of
• How significant a role will Invokana’s side-effect profile play in limiting physicians’ use of the product
• What percentage of patients will be prescribed Invokana prior to their progression onto injectable therapies
• How positive would physicians view the long-term approval of a product that combines canagliflozin with sitagliptin
Results and related analysis will be available for FirstWord Pharma PLUS subscribers, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase the findings. Please Alert me when the results and analysis from this poll are available.
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