Wins licensing for Onglyza/Farxiga dual-therapy after rejection by the FDA in 2015
The US FDA has approved AstraZeneca's Qtern, a two-drug therapy for type 2 diabetes, after rejecting the drug in 2015.
Qtern is a fixed dose combination product based on the active ingredients in AZ's DPP-4 inhibitor Onglyza (saxagliptin) and SGLT2 inhibitor Farxiga/Forixiga (dapagliflozin). It is the second combination of its type to be approved for marketing in the US after Eli Lilly and Boehringer Ingelheim's Glyxambi (linagliptin/empagliflozin).
The US regulator has approved the new drug as a once-daily therapy for adults with type 2 diabetes who can't control their blood sugar using dapagliflozin alone, or are already taking dapagliflozin and saxagliptin separately. AZ bagged approval for the same indication in Europe last year.
The FDA turned down Qtern with a request for more data 16 months ago, shortly before insisting on new labelling for saxagliptin and Takeda's rival DPP4 inhibitor Nesina (alogliptin) warning of an increased risk of heart failure.
Coupled with an earlier class-wide warning from the US regulator about joint pain, the warning seems to be pegging back growth of Onglyza, which declined 6% to $720m last year. AZ indicated earlier this month that so it far has only launched Qtern in the UK, with additional roll-out in the EU and US due later in 2017.
At one point the UK group suggested Qtern would become a $3bn product at peak, but the delay to approval and Glyxambi's lead in the big US market presents a big challenge to those ambitions. That said, analysts at Credit Suisse have suggested last year that AZ's drug could become a $950m product in 2020, behind Glyxambi at around $1.05bn in the same year.
"Type 2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone," said Elisabeth Björk, who heads metabolic and cardiovascular drug development at AZ.
"The approval of Qtern is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet."
SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney, while DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
In 2013 AZ agreed a $4.3bn deal with Bristol-Myers Squibb to take control of the companies’ diabetes joint venture, taking sole rights to Onglyza and Farxiga as well as other drugs such as GLP-1 agonist Bydureon (exenatide).