U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca, delaying its launch and dealing a blow to an important plank of the drugmaker's business. Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.
Last year, during its defense against a $118 billion takeover attempt by Pfizer, AstraZeneca predicted the saxagliptin and dapagliflozin fixed-dose combination could generate peak annual sales of $3 billion, out of total diabetes revenue of $8 billion expected by 2023.
The individual component drugs in the new mix are already approved and marketed for the treatment of type 2 diabetes, under the brand names Onglyza and Farxiga, and the FDA move is not expected to affect their status, the company added.
Sales of Onglyza reached $391 million in the first half of 2015, with recently launched Farxiga selling $205 million.
Onglyza is a type of diabetes medicine known as a DPP-IV inhibitor, similar to Merck's highly successful Januvia. Farxiga belongs to a newer drug class called SGLT2 inhibitors, which have created great excitement since a clinical trial last month showed that Eli Lilly's Jardiance slashed deaths in patients at risk of heart attack and stroke.7/=-09543ES
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