October 26, 2011 / 9:01 PM / in 6 years

UPDATE 1-FDA delays verdict on Astra/Bristol diabetes pill

* FDA to decide on dapagliflozin by Jan. 28, 2012

* Companies submit more data in response to FDA request

* FDA advisers had doubts about lack of data on safety

Oct 26 (Reuters) - U.S. drug regulators said they need three more months to decide whether to approve a new type of diabetes pill from AstraZeneca and Bristol-Myers Squibb .

The Food and Drug Administration said it would push back its decision date to Jan. 28, 2012 on dapagliflozin, a once-a-day drug to treat adults with Type 2 diabetes.

The announcement comes after the companies submitted new data from Phase 3 clinical trials in response to a request from the agency, according to a company press release.

“This data submission constitutes a major amendment to the original new drug application for dapagliflozin,” according to the release.

In July an FDA panel of outside experts voted against recommending approval of the drug over concerns about liver injury and cancer risks, pointing to clinical data that did not provide enough certainty about the drug’s safety.

The original FDA decision date was this Friday. But analysts have said the panel’s negative recommendation in July meant FDA approval could get pushed back further, perhaps as much as one to two years, if the companies are forced to conduct extra studies.

Bristol shares fell 0.7 percent in after-market trading on the New York Stock Exchange, while AstraZeneca shares nudged down 0.2 percent.

People with diabetes have inadequate blood sugar control, which can lead to heart disease and stroke, damage to the kidneys or nerves, and blindness.

Dapagliflozin belongs to a new class of diabetes drugs designed to allow more sugar to be excreted with urine.

But in a two-year study, nine people taking the drug got bladder cancer, and nine got breast cancer, out of 5,478 patients treated. The FDA advisers in July also worried about how effective the drug would be in the elderly, many of whom have kidney problems.

An estimated 200 million people across the world, and close to 26 million in the United States, have diabetes. Most have Type 2 diabetes, the kind linked to poor diet and lack of exercise.

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