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Published on : Oct 20, 2015

AstraZeneca’s new drug made combining dapagliflozin and saxagliptin has been delayed as United States Food and Drug Administration (FDA) wants to put it through a few more trials before it hits the market. The new drug has been especially designed to treat Type 2 diabetes patients.

Unfortunately, with this delay marks yet another setback for AstraZeneca. The earlier one was postponement for two trials for combined cancer drugs. In a new effort to make the diabetes drug a success, the company stated that it will closely work with FDA to figure out the appropriate steps for the trials. On the other hand, FDA has sent a Complete Response Letter to AstraZeneca seeking complete information that will elaborate and elucidate the research done for the drug for further approval.

A Deutsche Bank analyst, Richard Parkes stated that FDA maybe have delayed the approval due to the lack of accurate data supporting the drug than the safety concerns. According to him the launch will now be delayed by about a year or two. 

Affirming the long delay of the drug, a spokesperson Vanessa Rhodes, stated that AstraZeneca is unsure about when it will be able to make the re-submission for its applications.

Last years, AstraZeneca estimated that the new drug could lead to annual sales worth US$3 billion out of the overall diabetes drug-related revenue of US$8 billion predicted by 2023. The company further reported that sales for Onglyza (saxagliptin) reahced US$391 million in the first six months of 2015, whereas the sales of Farxiga (dapagliflozin) was totaled at US$205 million.

AstraZeneca stated that the new drug could reduce the blood sugar level of the patient drastically as compared to the taking just one drug. The combination of this drug along with metformin would be the first step to treating diabetes.