Boehringer and Lilly's diabetes drug Jardiance approved in Europe
The European Commission has approved Jardiance, a new diabetes treatment co-marketed by Boehringer Ingelheim and Lilly.
Jardiance (empagliflozin) is the latest in the sodium glucose co-transporter 2 (SGLT2) inhibitor class to join the market for treatment of type 2 diabetes.
The drug joins Janssen's Invokana (canagliflozin) and AstraZeneca's Farxiga /Forxiga (dapagliflozin). The approval is good news for Boehringer and Lilly, after the FDA refused to approve the drug after problems with its production at a Boehringer manufacturing site were uncovered.
Analysts forecast that each of the SGLT2 drugs could come close to the $1 billion mark in peak sales, depending on further large-scale trials to prove their safety and efficacy compared to existing diabetes treatments.
Jardiance has shown similar pros and cons to the other SGLT2 drugs - when used as monotherapy, most patients were free from weight gain, low blood sugar and gastrointestinal issues seen in older diabetes drugs. However genital infection, urinary tract infection and increased urination is a problem with the drug and other SGLT2 drugs. Genital infection and urinary tract infection were more common in women than men.
Jardiance has an advantage over Forxiga, as AstraZeneca's drug must carry a label warning of increased risk of bladder cancers seen in trials.
"The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe," said Enrique Conterno, President of Lilly Diabetes. "We are proud to continue with our commitment in supporting the varied treatment needs of people living with Type 2 diabetes."
The approval is particularly important for Lilly, which is looking to establish a set of new products to replace a generation of big sellers in the process of going off patent.
Lilly has a number of projects in the diabetes field, including its long-acting GLP-1 agonist dulaglutide. The drug recently showed non-inferiority to Novo Nordisk's established player in the field, Victoza.