- An advisory panel to the Food and Drug Administration narrowly voted in favor of allowing Boehringer Ingelheim and Eli Lilly to claim their diabetes drug Jardiance cuts the risk of cardiovascular death, the company said Tuesday.
- In a 12-11 vote, panelists agreed substantial evidence existed to support the claim based on findings from the EMPA-REG clinical trial. Jardiance was the first drug clinically proven to reduce the risk of cardiovascular death, a significant co-morbidity for patients with disease.
- If the FDA concurs with the panel's decision, sales of Jardiance would likely receive a boost and analysts expect a label expansion to raise the profile of the entire class of SGLT-2 drugs.
Tuesday's vote was closer than perhaps Lilly and Boehringer expected. Panelists on the Endocrinologic and Metabolic Drugs Advisory Committee raised concerns over the lack of a second trial confirming the cardiovascular benefit findings from the EMPA-REG study, according to Reuters.
While that data from EMPA-REG was convincing, the FDA usually likes to see multiple trials. The FDA is not required to follow the advice of an advisory panel, but it usually does.
"Today's robust discussion and resulting vote are important as we look to gain approval of a new indication for Jardiance as the first type 2 diabetes treatment to provide a cardiovascular benefit," said Thomas Seck, vice president of Clinical Development and Medical Affairs for Metabolism at Boehringer.
A forecast from EP Vantage predicts SGLT-2 diabetes drugs, which include Jardiance as well as Johnson & Johnson's Invokana and AstraZeneca's Farxiga, will become one of the top-selling drug classes for the condition by 2022.
Both J&J and AstraZeneca are testing their drugs for a cardiovascular benefit, although results aren't expected until next year for Invokana and until 2019 for Farxiga.
If the FDA approves an expanded indication for Jardiance, Boehringer and Lilly would have a substantial head start on their competitors in the SGLT-2 class.
But in the overall diabetes market, other drugmakers are already catching up. Novo Nordisk recently released data showing their injectable GLP-1 drug Victoza cut the risk of cardiovascular events by 13%, making it the first drug to show a heart benefit after Jardiance.
EP Vantage pegs 2022 sales of Jardiance at $3.9 billion, while forecasting $4.17 billion for Victoza.
Eli Lilly stock rose by nearly 2% in early trading Wednesday.