AstraZeneca Plc. (LON: AZN) failed to obtain U.S. approval from the FDA for a new treatment for diabetes. Regulators asked the company for more clinical trials.
The new treatment combines two of their existing drugs: saxagliptin and dapagligiozin. AstraZeneca announced that they will work with the FDA to determine the next steps in order to get the approval.
The company stated that this procedure does not affect interactions with other health authorities. “Based on the information available, the CRL is not expected to affect individual components of saxagliptin or dapagliflozin, which are approved for the treatment of adult patients with type 2 diabetes,” reads a press release.
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According to Bloomberg, on October 9 AstraZeneca reported they were temporarily suspending two trials combining cancer drugs due to reports of lung disease. As this happens, rivals like Sanofi, Novo Nordisk and Eli Lilly & Co. are also looking to introduce new diabetes treatments. This is the second time that the treatment approval is delayed.
A ‘couple’ to fight diabetes
Saxagliptin, better known as Onglyza, is a drug that helps the body to produce more insulin, removing sugar from the blood. The other component, Dapagliflozin, also known as Farxiga, blocks sugar from getting into the kidneys, helping to control diabetes.
Statistics say that about 382 million people suffer from diabetes, according to the International Diabetes Federation. This treatment is aiming to help people with diabetes type 2, a disease that tends to appear later in life, linked with obesity and a sedentary lifestyle.
Source: AstraZeneca