FDA Delays Dapagliflozin Decision Again

November 8th, 2011 by Ryan Luce No Comments

written by Michael O’Leary

The quest for FDA approval of type 2 diabetes drug, dapagliflozin, will drag on at least several more months.

The FDA panel evaluating the drug’s safety was to review additional data from clinical trials and reach a decision on whether or not it would recommend approval of the drug for sale on Friday, Oct. 28, 2011. The panel, however, has now pushed back its decision to at least Jan. 28, 2012. (Link to published site)

The drug’s makers, Bristol-Myers Squibb and AstraZeneca, at the FDA’s request last August, submitted data gathered in phase three clinical trials after the FDA requested additional research. Phase three clinical trials involve large numbers of people randomly assigned to treatment groups to compare the safety and effectiveness of those treatments.

In their announcement the companies said the amount of new data submitted was substantial.

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

The FDA panel looked at the additional data and decided it would need at least three more months to evaluate the approval application.

Dapagliflozin differs from all other drugs available including DPP-4 (Onglyza®, Januvia®) and GCP-1 (BYETTA®) that work on the insulin side of metabolism. Dapagliflozin works with a more comprehensive mode of action that slows or blocks absorption of glucose in the kidneys so that sugar is excreted in the urine.

The 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.

In two studies presented at the American Diabetes Association (ADA) 71st Scientific Sessions last June and reported on by Corengi, dapagliflozin in combination with metformin was found to lower blood glucose levels more either agent alone in patients with newly diagnosed type 2 diabetes.

At week 24 in one study, 52.4 percent of patients in the combination group had an HbA1c level of 7 percent or less compared with 34.6 percent with metformin alone and 22.5 percent with dapagliflozin 5 mg alone.

Similarly, in the second study after 24 weeks, 46.6 percent of patients in the combination group had an HbA1c level of 7 percent or less compared with 35.2 percent with metformin alone and 31.7 percent with dapagliflozin 10 mg alone. In addition, the patients in the dapagliflozin groups achieved an average weight loss of seven pounds.

While those are promising results, the FDA panel was concerned with the adverse events that occurred among all patients in the clinical trials program for the drug. There have been nine breast cancers and nine bladder cancers among 5,478 patients in the dapagliflozin groups compared to only 1 breast and bladder cancers among the 3,156 patients assigned to comparison groups. The FDA reviewers said the drug is also implicated in liver damage in at least one and possibly two people.

There are currently three ongoing dapagliflozin clinical trials that are still recruiting patients. To see if you might be eligible, check the listings on the Corengi Search page.