FDA Scheduled to Take Major Actions On Eli Lilly Drug Next Week

fdaOn Tuesday, major drug companies will face key US Food and Drug Administration actions that will very likely affect the future of their industry-leading disease-treatment properties.

Yes, on this coming Tuesday, an FDA advisory committee will meet to discuss the expansion of the Jardinance label. This is Eli-Lilly’s 2-year-old drug for the treatment of type 2 diabetes. Eli Lilly wants to add to the label the notification that the drug can reduce cardiovascular death as well as likelihood of hospitalization caused by heart failure and the risk of overall death.

The claims made by Eli Lilly have been based on the large and long term trial known as EMPA-REG, whose results were surprising last year when the study concluded. The results suggest that Jardinance showed a 38 percent reduction in death due to cardiovascular causes as well as a 35 percent reduction in hospital visits due to heart failure and a 32 percent reduction in overall death.

Of course, Eli Lilly wants to add this to the label, which means they can use these impressive statistics in their marketing strategy.

Now, it might seem that this should be a no-brainer but there is a problem: According to Leerink analyst Seamus Fernandez, these results were not the primary endpoints of the initial trial. These results are secondary “explanatory” endpoints.

The primary endpoint was a three-prong measurement of major adverse cardiac events. These are the durations until: first cardiovascular-related death, non-fatal heart attack, and non-fatal stroke.

The FDA released its original briefing document for the panel on Friday morning. In it, the agency concluded to recommend against changing the label, citing “we rarely give indications for reducing the risk of all-cause mortality in CV outcome trials because this endpoint is typically driven by CV death.”

Thus, in a June 2 report, Fernandez comments, “Look for FDA panel to be a battle of ‘statistical purists’ vs ‘clinicians.’ Several FDA presentations would suggest that the trial was not designed to allow a CV death endpoint. But clinically, the large and consistent CV death benefit seen in the EMPA-REG trial is viewed to be precedent-setting.”

Maybe more importantly, this precedent will also be of great interest to other companies; Novo Nordisk, for example, recently reported a similar study of its Victoza diabetes drug.

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