UPDATED: Boehringer, Lilly tout PhIII results for another SGLT2 drug

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CHIGAGO--Diabetes partners Boehringer Ingelheim and Eli Lilly ($LLY) revealed that their SGLT2 diabetes drug empagliflozin held its own in a slate of Phase III trials, yet the available clinical data make it difficult to show how the experimental treatment stands out from the rest of the drugs in the same class.

At the American Diabetes Association's (ADA's) annual meeting here, major players in the diabetes market have been highlighting data on their SGLT2 inhibitors, which trigger the exit of glucose out of the body via urine, working separately from insulin. Ingelheim, Germany-based Boehringer has shed light on an analysis from four Phase III studies of empagliflozin, showing that the drug provided significant reductions in average blood glucose, blood pressure and body weight. On the safety side, the data show that patients on the drug had a greater chance of having genital infections, a side effect that is likely to come up again during regulatory reviews.

Boehringer and Lilly submitted the drug for approvals in the U.S. and Europe in the first quarter of 2013 in hopes of winning an approval for one of several drugs involved in their diabetes collaboration that was formed in January 2011. Even if regulators approve empagliflozin, there are not much clinical data to show how the drug is different from Johnson & Johnson's ($JNJ) Invokana or Forxiga from AstraZeneca ($AZN) and Bristol-Myers Squibb ($BMY), to name just two of several other SGLT2 compounds.

"I think probably from a clinical perspective, there is no big difference between the [SGLT2] compounds so far, at least from everything we have seen," Dr. Maximilian von Eynatten, a clinical development director at Boehringer, said in an interview here at the ADA meeting. "Ultimately, it's going to be used by real patients in the real-world setting. So let's see what the future brings."

At this point, the SGLT2 drug class is relatively new and has only recently been added to treatment guidelines for Type 2 diabetes, which causes patients to lose their ability to produce enough insulin to keep blood sugar levels under control. As von Eynatten noted, there have been no major head-to-head studies of the treatments.

In a June 17 note to investors, ISI Group analyst Mark Shoenebaum pointed out several similarities and no significant differences between BI and Lilly's empagliflozin and J&J's Invokana, writing that the experimental drug was "undifferentiated" from the approved therapy.

There are serious concerns about the safety of these drugs, including worries about potential cardiovascular side effects and cancer. Last year the FDA denied approval of BMS and AZ's dapaglifozin, seeking data to address their concerns about cancer cases in study patients. European regulators approved the drug, marketed as Forxiga, late last year. Johnson & Johnson won the first FDA nod for an SGLT2 drug this year for Invokana, yet the agency is requiring J&J to do 5 postmarketing studies, including a major cardio outcomes trial and studies to monitor any cases of cancer and pancreatitis in patients on the treatment.

As long as empagliflozin passes the safety test and meets efficacy expections, the lack of meaningful clinical differentiation seems unlikely to bother regulators. The diabetes market includes many drugs with the same mechanisms.

- here's the release from BI and Lilly

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Editor's note: A Boehringer Ingelheim spokeswoman told me after this article was published that the direct quote from Dr. Maximilian von Eynatten of BI was taken out of context. I disagree. Below I have included a transcript of my question and his answer from our discussion about empagliflozin. I have italicized the part of Dr. Maximilian von Eynatten's answer included in the direct quote. I hope this makes clear exactly what Dr. Maximilian von Eynatten meant to say.

  • Me: So bottom line, what kind of profile distinguishes it from, say, Invokana (J&J's drug from the same class)?
  • Dr. Maximilian von Eynatten: I think that's probably from the development program, so far from a clinical aspect, both provide the benefits we mentioned. There's glucose control. There's loss of body weight. There's also the systolic blood pressure drop. I think, I think probably from a clinical perspective, there is no big difference between the compounds so far at least from everything that we have seen. Ultimately, right, medications going to be used in real patients in the real-world setting, so let's see what the future brings. Also, the outcome studies are different between the compounds in the class. They do address different populations, different duration. The magnitude of those trials are different. I think we're going to learn, we're going to learn along the next couple of months and years if there are clinically relevant differences.