NEW YORK European regulators have approved the first in a new class of diabetes medicines that work independently of insulin to control blood sugar, the drug's developers Bristol-Myers Squibb Co and AstraZeneca Plc said on Wednesday.
The approval of Forxiga by the European Commission stands in stark contrast to the rejection of the drug in January by U.S. regulators, who cited concerns about the risk of cancer and liver injury and asked for more clinical data on the once-daily tablets.
The European Medicines Agency in April said it was satisfied those issues had been addressed in the drug's product label and via a risk management plan for the medicine. But many industry analysts believe the drug's dim prospects in the larger U.S. market will sharply curtail its potential sales.
The European Commission on Wednesday approved Forxiga, which works by blocking a protein called SGLT2, or sodium-glucose cotransporter 2. It is meant to be used in combination with other treatments for type 2 diabetes, including insulin, or as a standalone treatment for patients who cannot tolerate the widely used oral treatment metformin.
Bristol-Myers and AstraZeneca said Forxiga in clinical trials was associated with a low risk of hypoglycemia, a side effect of many diabetes drugs in which blood sugar drops to levels that cause fainting and other dangerous complications.
Use of the drug in clinical trials was also associated with about a 2 to 3 percent decline in body weight, as well as declines in systolic blood pressure.
"No other oral diabetes drug also lowers blood pressure and induces weight loss," Elisabeth Bjork, head of cardiovascular medicine at AstraZeneca said in an interview. By contrast, insulin and a widely used class of medicines called sulfonylureas are associated with weight gains.
Fred Fiedorek, cardiovascular head at Bristol-Myers, said the company aims to resubmit its U.S. marketing application for Forxiga by mid-2013.
"We are looking forward to getting approvals everywhere, and that includes with the FDA," Fiedorek said in an interview. He said Bristol-Myers and AstraZeneca officials have been meeting with FDA officials to ensure the agency has the data it needs.
Johnson & Johnson is awaiting approval of its own SGLT2 inhibitor, canagliflozin. Like Forxiga, it blocks reabsorption of glucose by the kidney and increases glucose excretion in the urine to lower blood sugar, and is also associated with drops in body weight and blood pressure.
Shares of Bristol-Myers slipped 0.9 percent to $31.57, while AstraZeneca fell 0.7 percent to $45.12, both on the New York Stock Exchange, amid similar declines for the broad stock market.
(Reporting By Ransdell Pierson; Editing by Tim Dobbyn and Marguerita Choy)
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