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United Kingdom drugs company AstraZeneca faces a setback in the USA, after failing to win government backing for its diabetes treatment.
AstraZeneca has great hopes from the drug combination.
The FDA, in a complete response letter (CRL), told the company to provide more clinical data for the type 2 diabetes medication - a combination of saxagliptin and dapagliflozin drugs.
In a statement, AZ said that a few of this information could come from completed or ongoing studies, but it did not rule out the possibility of having to carry out additional trials, potentially delaying approval for a few time. These include Eli Lilly & Co, Sanofi and Novo Nordisk.
The CRL states that more clinical data are required to support the application.
AstraZeneca says this announcement does not affect ongoing interactions with other health authorities as part of these individual application procedures. AstraZeneca’s shares fell 1 percent in early trading on Friday, underperforming a 1 percent rise in the European drugs sector, Reuters reported. As per AstraZeneca, the individual component drugs used in the combination have already been approved and being sold for the treatment of type-2 diabetes.
Sales of Onglyza reached US$391 million in the first half of 2015, with recently launched Farxiga selling US$205 million.
SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney, while DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
