The launch for the new diabetes treatment from a biopharmaceutical company AstraZeneca has been delayed as the United States Food and Drug Administration (FDA) requires more clinical trial data for the treatment. AstraZeneca had combined a fixed dose for two of its drugs called dapagliflozin and saxagliptin in a new treatment for Type 2 diabetes patients.
This is currently the second setback for AstraZeneca in its goal of bringing more treatments to market. The company had temporarily postponed two of its trials which combined cancer drugs.
The drug company said that it will work closely with the FDA to determine the appropriate steps for their application. The FDA sent a Complete Response Letter to the company, asking for more elaborate research and information until the treatment becomes approved.
Richard Parkes, a Deutsche Bank analyst, said FDA probably noted the lack of data on the treatment's formulation rather than safety concerns. He assumed that the launch would likely be delayed for a year or two.
Vanessa Rhodes, a spokesperson for AstraZeneca, said that the company can't yet say when it will be able to re-submit its application.
"This announcement does not affect ongoing interactions with other health authorities as part of these individual application procedures," the company explained.
In 2014, AstraZeneca predicted that the new treatment could generate peak annual sales of $3 billion out of total diabetes revenue of $8 billion expected by 2023. Sales for Onglyza (saxagliptin) accumulated $391 million in the first half of 2015, while sales for Farxiga (dapagliflozin) reached $205 million.
AstraZeneca said that in a late-stage clinical trial, the new diabetes drug combination reduced patient's blood sugar levels more than when one drug is taken alone. The treatments were combined with metformin, an inexpensive generic drug which is typically the first step in treating diabetes.
Onglyza (saxagliptin) is a DPP-IV inhibitor and it can help the pancreas create more insulin which is a hormone that regulates sugar from the blood. Farxiga (dapagliflozin) is an SGLT-2 inhibitor and it blocks excess sugar from being absorbed into the kidneys.
AstraZeneca estimates that more than 29.1 million people in the U.S. and over 387 million people worldwide are affected by diabetes. The prevalence for the disease may possibly increase to 592 million people by 2035. In the U.S., 95 percent of diabetes cases are classified as Type 2 diabetes.