AstraZeneca Plc failed to win U.S. approval for a new diabetes treatment that combines two of its existing drugs after regulators asked for additional data that may require new clinical trials.
The drugmaker will work closely with the Food and Drug Administration to determine the next steps and remains committed to developing the combination of saxagliptin and dapagliflozin, London-based AstraZeneca said in a written statement Friday. Following Thursday’s deadline for the agency to make a decision on an application seeking approval for the treatment, the FDA issued a so-called complete response letter, requesting further data.
The delay is the second setback in as many weeks for AstraZeneca in its push to bring more treatments to market. The company on Oct. 9 said it was temporarily halting two trials combining cancer drugs due to reports of lung disease. Meanwhile, rivals such as Paris-based Sanofi, Denmark’s Novo Nordisk A/S and Indianapolis-based Eli Lilly and Co. are racing to introduce new diabetes treatments amid a global pandemic.
Lilly shares rose almost 1 percent in morning trading Friday, to $80.57 each.
“This is clearly bad news for Astra,” Sam Fazeli, an analyst with Bloomberg Intelligence, wrote in e-mailed comments Friday. “It’s not clear how long they will have to wait.”
The combination would have competed with Glyxambi from Lilly, a drug that now has “a clear run in the U.S.,” said Fazeli.
AstraZeneca’s therapy could generate at least $850 million in sales by 2020, Fabian Wenner, an analyst at Kepler Cheuvreux, had earlier estimated.
More clinical data would come from ongoing or completed studies, and new studies may also be needed, AstraZeneca said. The company can’t yet say when it will be able to re-submit its application, spokeswoman Vanessa Rhodes said by phone.
AstraZeneca stock was mostly unchanged in London trading after earlier dropping as much as 1.9 percent. The stock has declined 9.5 percent this year.
In a late-stage clinical trial, AstraZeneca’s combination therapy helped patients reduce blood sugar levels more than either drug alone, the company said last year. In both cases the treatments were combined with metformin, a cheap generic drug that’s usually the first step in treating diabetes.
Saxagliptin, marketed under the brand name Onglyza, is part of a class of drugs called DPP-4 inhibitors. The treatments help the body make more insulin, which helps remove sugar from the blood. Dapagliflozin, 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.
AstraZeneca in 2013 agreed to pay as much as $4.3 billion to buy Bristol-Myers Squibb Co.’s share of the companies’ joint venture to make diabetes drugs, giving the company sole control of new treatments such as Onglyza and Farxiga as well as the medicines Bydureon and Byetta.
About 382 million people globally have diabetes, in which the pancreas fails to produce enough insulin to convert glucose into energy, according to the International Diabetes Federation. The variant known as type 2 tends to strike later in life, brought on by obesity and sedentary lifestyles, as people become resistant to the insulin their own body produces.