written by Michael O’Leary
A FDA panel dealt a setback to Bristol-Myers Squibb Co. and AstraZeneca PLC last week voting 9-6 not to recommend approval dapagliflozin for treatment of type 2 diabetes. The blow came as a bit of a surprise to experts who had expected the panel to approve the drug with some post marketing requirements due to some adverse complications. (Link to published site)
Dapagliflozin, the first in a new class of drugs for type 2 diabetes differs from all other drugs available including DPP-4 (Onglyza®, Januvia®) and GCP-1 (BYETTA®) that work on the insulin side of metabolism. Dapagliflozin takes a more comprehensive approach to controlling HbA1c by slowing the absorption of glucose in the kidney.
According to the Bristol-Myers announcement, the approval turned on a single question posed to the panel members – “Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?” Only six of the 15 panel members answered yes.
The vote was foreshadowed earlier this week when the same panel reviewed the clinical trial data. They raised concerns about breast and bladder cancers that occurred during a series of clinical trials testing the drug. Among 5,478 patients who had taken dapagliflozin during the trials there were nine breast and nine bladder cancers. By comparison there was only 1 breast and 1 bladder cancer among the 3,156 patients who did not receive the drug in those clinical trials.
The panel also raised questions about the drug’s potential for liver damage, and a relatively high number of urinary tract infections that ranged from about seven to 11 percent of the patients taking the drug during the trials.
Despite those concerns the companies remain hopeful that additional clinical trials will show a convincing benefit for type 2 diabetes patients. The FDA is not bound by the advisory panel’s recommendation, however it usually follows its advice. (Linked to published site)
The vote was foreshadowed earlier this week when the same panel reviewed the clinical trial data. They raised concerns about breast and bladder cancers that occurred during a series of clinical trials testing the drug. Among 5,478 patients who had taken dapagliflozin during the trials there were nine breast and nine bladder cancers. By comparison there was only 1 breast and 1 bladder cancer among the 3,156 patients who did not receive the drug in those clinical trials.
The panel also raised questions about the drug’s potential for liver damage, and a relatively high number of urinary tract infections that ranged from about seven to 11 percent of the patients taking the drug during the trials.
Despite those concerns the companies remain hopeful that additional clinical trials will show a convincing benefit for type 2 diabetes patients. The FDA is not bound by the advisory panel’s recommendation, however it usually follows its advice. (Linked to published site)
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