FDA Reschedules Decision on Dapagliflozin, as Reported by DiabeticLive.com
According to the regulators at the U.S. Food and Drug Administration, they will need three more months of research to determine the approval status of a new type of diabetes medication developed by Bristol-Myers Squibb and AstraZeneca as reported by DiabeticLive.com.
Orlando, FL (PRWEB) October 28, 2011
According to the regulators at the U.S. Food and Drug Administration, they will need three more months of research to determine the approval status of a new type of diabetes medication developed by Bristol-Myers Squibb and AstraZeneca. The FDA announced that the decision on the medication’s approval will be pushed back to January 28, 2012. The medication is called dapagliflozin and is a once-daily medication designed to treat Type 2 diabetes in adult patients.
Bristol-Myers Squibb and AstraZeneca submitted data gathered in Phase 3 clinical trials after the FDA requested additional research.
“This data submission constitutes a major amendment to the original new drug application for dapagliflozin,” stated a press release from the company.
An FDA panel previously voted against recommending the drug’s approval due to concerns that it could increase risk of cancer and cause liver injury. The panel’s vote came earlier this year in July and pointed to data from clinical trials that did not positively establish the drug’s safety.
The FDA’s decision was originally scheduled for Friday, October 28, 2011. According to analysts, however, the panel’s recommendation against approval could push the FDA decision back even farther, as much as a year or two, due to the need to conduct additional trials.
Dapagliflozin seeks to remedy the poor blood sugar control that causes diabetics to face a host of complications, from vision loss to nerve and kidney damage to stroke and heart disease. The drug is part of a new type of diabetes medications that cause the individual to excrete more sugar through the urine, reducing glucose levels in the blood.
A two-year study conducted on dapagliflozin had troubling results. Out of 5,478 patients treated with the medication, nine developed bladder cancer and another nine developed breast cancer. The FDA panel’s decision to recommend against the drug’s approval pointed to these findings and also questioned the drug’s effectiveness in the elderly, where pre-existing kidney problems could be exacerbated.
Current estimates place the number of individuals with diabetes around the world at 200 million, with 26 million in the United States alone. Most of them have Type 2 diabetes, a condition associated with obesity, lack of exercise, and an unhealthy diet.
Dapagliflozin could be used to treat individuals with Type 2 diabetes as well as those with Type 1 diabetesÃ¢”a variant of the disease in which the autoimmune system attacks the beta cells of the pancreas and reduces production of insulin. Dapagliflozin works by inhibiting sodium-glucose transport protein (SGLT2), which blocks glucose reabsorption in the kidney and causes sugar to be excreted through the urine.
Two studies were conducted on the efficacy of the medication, comparing results from patients using dapagliflozin alone, metformin alone, and dapagliflozin along with metformin over a period of 24 weeks. The two groups different in the dosage of dapagliflozin that they received: one group received 5mg doses and the other received 10mg doses.
Findings indicated that the groups using dapagliflozin combined with metformin showed the greatest decreases in HbA1c levels: in the group receiving dapagliflozin 5mg, 52.4 percent of the combination group had hemoglobin levels below 7 percent, compared to 34.6 percent of those using metformin alone and 22.5 percent of those using dapagliflozin alone. In the group taking dapagliflozin 10mg, 46.6 percent of the combination patients had hemoglobin levels below 7 percent compared to 35.2 percent of patients taking metformin alone and 31.7 percent of those taking dapagliflozin alone.
For the original version on PRWeb visit: http://www.prweb.com/releases/prwebDiabetes/Dapagliflozin/prweb8918126.htm