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FDA Approves Jardiance Claim to Cut Cardio Risks, Death

Panel further assessing date that SGLT-2 drug shows actual benefit for heart

Guest article by David Kliff

On June 28th an FDA advisory panel voted 12-11 to allow the claim that Jardiance, an SGLT-2 from Lilly (NYSE: LLY), cuts the risk of cardiovascular death. The panel also voted unanimously that the drug does not add to the risk of cardiovascular problems. While this vote was closer than Lilly would have liked, it’s still a major victory and puts even more pressure on Johnson and Johnson (NYSE: JNJ) who makes Invokana and AstraZeneca (NYSE: AZN) who makes Farxiga, two SGLT-2’s that just underwent an adverse label change due to possible kidney issues.

Back when the EMPA-REG data was disclosed, we speculated that JNJ and AZN would first claim the cardiovascular benefits seen with Jardiance were a class effect. We added that when the Invokana cardiovascular data comes out next year and the Farxiga data comes out in 2019, there we would the inevitable parsing of data sets. What we did not anticipate was the panel having concerns over the EMPA-REG data.

According to a story posted on the FiercePharma website:

“But advisory committee panelists expressed some concerns Tuesday that echoed those expressed by the FDA itself in premeeting briefing documents. For one, EMPA-REG is a single study initially designed to assess safety outcomes, and ‘the FDA has asserted that two confirmatory studies are typically required’ to widen a label, Evercore ISI analyst Mark Schoenebaum wrote in a midday note to clients Tuesday.

Regulators also asked committee members to consider the 124 nonassessable deaths that occurred during the study; as the FDA wrote in its briefing documents, those could have altered the study’s results.”

Given that the FDA typically follows the panel’s advice and we see no reason that this time will be any different, this concern over the EMPA-REG data provides a moment of pause. Unfortunately, as we learned from the now infamous meta-analysis that lead to the demise of Avandia, study data is open to interpretation and two experts can look at the exact same data set and reach two very different conclusions. The meta-analysis and the controversy it created also showed what happens when the numbers are played with.

Herein is where we see a possible issue given that the FDA is being asked to allow Jardiance to claim a cardiovascular BENEFIT, which is a much higher claim than the drug does no harm. Let’s be clear here we do believe the FDA will follow the panel’s advice, however the closeness of the vote and the concerns expressed over study design and interpretation of results does provide a moment of pause.

For the moment, Lilly is riding the EMPA-REG data all the way to the bank as the data is finally impacting prescribing decisions and market share. JNJ and AZN are caught in the unfortunate position of not having any hard data that proves the cardiovascular benefits seen with Jardiance are indeed a class effect, and as we noted both Invokana and Farxiga were hit with an adverse label change while Jardiance was not. This is beginning to make the experts question whether all SGLT-2 work the same way.

As we noted previously, physicians are a notoriously risk-adverse group and given all the available data, prescribing Jardiance is the safest option. Payors are now in the unusual position of justifying NOT having Jardiance as their preferred SGLT-2. This could force JNJ and AZN to either lower prices and/or increase rebates to remain competitive.

So what does this all mean? First we don’t see physicians switching patients on either Invokana or Farxiga to Jardiance. We do, however, believe that Jardiance not surprisingly will get the lion’s share of new patient starts. We also believe that all of the SGLT-2’s will benefit from the EMPA-REG data just not equally – Jardiance is the clear winner – Invokana thanks to strong formulary presence and good advance work by JNJ will remain competitive while Farxiga will see share grow much more slowly.

Our longer term concern here is the inevitable debate that’s coming as the EMPA-REG data gets analyzed over and over. The silver lining this time around is that we are not debating whether a drug has an adverse impact rather a positive impact. We are not questioning the motives of the EMPA-REG researchers as we did when our friend, that crusading cardiologist, leaked the results of his now debunked meta-analysis.  Unlike GlaxoSmithKline (NYSE: GSK) who got hammered relentlessly during the Avandia controversy, unjustly as it turned out, Lilly is looking a hero.

Let’s hope for their sake that the sunlight that is currently shining on them does not turn to dark clouds as the EMPA-REG data gets put through the data meat grinder.

David Kliff
Publisher
Diabetic Investor
www.diabeticinvestor.com