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AstraZeneca denied FDA backing for Diabetes Treatment - UK-based pharmaceutical giant, AstraZeneca PLC, has failed to win US FDA's backing to sell the first in a new class of experimental diabetes medicines.
The US Food and Drug Administration (FDA) is seeking more data from current studies of the treatment, saxagliptin and dapagliflozin, in adults with Type 2 diabetes. And it might need new clinical trials to better assess the benefits and risks.
The delay is the second setback in as many weeks for the pharma firm in its push to bring more treatments to market. On Oct 9, AstraZeneca said it was temporarily halting two trials combining cancer drugs due to reports of lung disease.
Sam Fazeli, an analyst with Bloomberg Intelligence, said the combination would have competed with Glyxambi from Lilly, a drug that now has a clear run in the U.S. AstraZeneca's therapy could generate at least $850 million in sales by 2020, Fabian Wenner, an analyst at Kepler Cheuvreux, had earlier estimated.
AstraZeneca was largely unchanged at 4,122 pence as of 9:50 a.m. in London trading after earlier dropping as much as 1.9 percent. The stock has weakened 9.5 percent this year.
In a late-stage clinical trial, the company's combination therapy helped patients reduce blood sugar levels more than either drug alone. In both cases the treatments were combined with metformin, a cheap generic drug that?s normally the first step in treating diabetes.
Dapagliflozin, which is sold as Farxiga in the U.S., is an SGLT-2 inhibitor, a type of drug that blocks sugar from being absorbed into the kidneys. Instead excess sugar is excreted through the urine, helping control diabetes.
On the other hand, Saxagliptin, which is marketed under the brand name Onglyza, is part of a class of drugs called DPP-4 inhibitors. The treatments assist the body in making more insulin, which helps remove sugar from the blood.