The Plot Thickens

The Plot Thickens

Yesterday the FDA issued stronger warnings for two SGLT2’s Invokana and Farxiga, according to the warning;

“FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.”

This follows news from Lilly (NYSE: LLY) as their SGLT2 Jardiance, which was not included in this warning, cut the risk for new-onset or worsening kidney disease by 39%.

This news will likely send shivers down the spine of Johnson and Johnson (NYSE: JNJ), the makers of Invokana and AstraZeneca (NYSE: AZN), the makers of Farxiga. As we have been reporting the general feeling in the diabetes medical community is that the cardiovascular benefits seen with Jardiance will be replicated by Invokana and Farxiga, that this is a class effect. However, neither JNJ or AstraZeneca has any hard data that supports this belief.

Given that Jardiance was not included in the FDA warning combined with the additional data released from the landmark EMPA-REG study regarding kidney disease, it’s possible that all SGLT2’s may not be equal.  That while all these drugs are in the SGLT2 class they may not work the same way. Simply put Lilly has hard data which shows major cardiovascular benefits and positive impacts on kidney disease, while neither JNJ or AstraZeneca have any hard data yet on cardiovascular benefits and both were included in the FDA warning.

Taken as a whole all this data appears to give Lilly a major advantage something that will not be lost on payors. As we have been noting up until this new data came to light payors had no compelling reason to give Jardiance preferential treatment. The same goes for physicians. However, the FDA warning combined with the Lilly data on kidney disease could change all this. Given the choice between prescribing Jardiance which has hard data that shows numerous benefits or prescribing either Invokana or Farxiga, neither of which has hard data showing cardiovascular benefits and now a strengthened FDA warning for acute kidney injury, the safe play is to prescribe Jardiance.

The same goes for payors and this is where things get really interesting. Prior to this new warning JNJ had been playing up the fact that Invokana had preferential treatment with payors. Given that JNJ does not yet have hard data that proves it has similar cardiovascular benefits to Jardiance but does have a new warning on acute kidney injury payors just may rethink their position. Again as we have noted Lilly has yet to see increased sales of Jardiance since the EMPA-REG results became public. Something that is likely to change now that besides the cardiovascular benefits EMPA-REG also has shown kidney disease benefits.

Put bluntly EMPA-REG is producing an avalanche of positive data for Jardiance and the boulders are falling right on top of Invokana and Farxiga. It’s one thing when everyone believes that all the SGLT2’s produces cardiovascular benefits, it’s quite another when two of three have kidney issues. Let’s be honest here both payors and physicians are a risk adverse bunch and given the option they will avoid risk when they can. It seems the more that is known about the three SGLT2’s Jardiance is clearly emerging as the not just the most effective but also the safest choice.

As we see it even if the cardiovascular data from Invokana and Farxiga is BETTER than that seen with Jardiance it will NOT overcome the negative news on acute kidney injury. Even worse for JNJ and AstraZeneca payors and physicians may not wait for this cardiovascular data and begin making changes based on the increased kidney risk.

The EMPA-REG data has been transformative in many ways and could well propel Jardiance already on its way to blockbuster status to mega-blockbuster status.