AstraZeneca share price: EMDAC recommends dapagliflozin for treatment of type 2 diabetes

on Dec 13, 2013
Updated: Oct 21, 2019
Listen, Friday, December 13: The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has endorsed the use of the investigational SGLT2 inhibitor dapagliflozin, developed by AstraZeneca Plc (LON:AZN) and its US partner Bristol-Myers Squibb (NYSE:BMY), for treatment of type 2 diabetes in adults.

The committee voted yesterday 13 to one that the benefits of the drug outweigh identified risks, the two companies said in a statement. The decision comes nearly two years after the medicine was rejected by regulators on safety concerns.
In today’s London trading, AstraZeneca shares were 2.5 percent higher at 3,544.29p as of 11:13 UTC. Bristol-Myers closed marginally down at $50.55 yesterday.

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The FDA rejected the drug in January 2012 after a previous medical advisory panel concluded that clinical data did not provide enough certainty about its heart and cancer risks. In another vote yesterday, by 10 to four, the committee found that the medicine appears to have a favourable cardiovascular risk profile.

During yesterday’s meeting some members of the panel voiced concerns that 10 patients taking dapagliflozin in a clinical trial were later diagnosed with bladder cancer. But other members pointed out that in six of those patients the cancer appeared just months after the start of the treatment, meaning that those cases were probably unrelated to the medicine, with cancer typically taking years to develop.

ABC News quoted panellist Peter Savage of the National Institutes of Health who said that “the risk appears to be low enough to go ahead, but there is surveillance needed to make sure we’re not missing something.”
AstraZeneca and Bristol-Myers have agreed to monitor any reports of bladder cancer in an ongoing trial looking at strokes, heart attacks and other cardiovascular problems.

Dapagliflozin has already been approved by the EU and is sold in countries across the union, as well as in Australia, under the brand name Forxiga. An approval by the FDA would make it the second drug from the SGLT2 class that has been approved for use in the US. Earlier this year the regulator granted approval to Johnson & Johnson’s Invokana drug, which has enjoyed strong sales since. The success of Invokana underlines the commercial potential of the SGLT2 class. SGLT2 drugs work by removing the excess of sugar through the patient’s urine.
The FDA typically follows the recommendations of its advisory panels, but is not obligated to do so.
**As of 11:50 UTC buy AstraZeneca shares at 3,530.00p**
**As of 11:50 UTC sell AstraZeneca shares at 3,529.50p**
**As of yesterday’s US close buy Bristol-Myers shares at $53.65**
**As of yesterday’s US close sell Bristol-Myers shares at $48.69**
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