The Food and Drug Administration (FDA) said in order to make a final decision on the combined use of saxagliptin and dagagloflozin to treat type 2 diabetes, it requires more details about clinical trials in humans.
This includes the results of completed studies and also initial information from recently launched studies. AstraZeneca will “work closely” with the FDA to determine the appropriate next steps.
Type 2 diabetes, in which a person is unable to break down glucose effectively, results in dangerously high blood sugar levels. It currently affects an estimated 29m people in the US and 387m people worldwide, but these figures are set to rise as a result of the obesity pandemic.
A number of other pharmaceutical companies, aware of the growing need for diabetes treatments, are also racing to release approved medicines. These include Eli Lilly & Co, Sanofi and Novo Nordisk.
AstraZeneca said in a statement that the FDA's decision will not affect success of the drug in other markets:
This announcement does not affect ongoing interactions with other health authorities as part of these individual application procedures. Based on the information available, the decision is not expected to affect individual components of saxagliptin or dapagliflozin, which are approved for the treatment of adult patients with type 2 diabetes.
Shares in the company fell almost one per cent when markets opened, but have since risen back up. In mid-morning trading they hit 4,119p – a 0.1 per cent decline from yesterday.