Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee
Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical trials with the drugs be added to the drugs’ labels.
The two trials were the first large large cardiovascular outcomes trials of any diabetes drugs. SAVOR-TIMI 53 studied saxagliptin (Onglyza, AstraZeneca) and EXAMINE studied alogliptin (Nesina, Takeda Pharmaceuticals). Both trials were neutral, finding no evidence of either cardiovascular benefit or cardiovascular harm with the drugs, which are DPP-4 inhibitors.
In the morning the committee voted 13-1-1 that saxagliptin had an acceptable cardiovascular risk profile. In the afternoon it was alogliptin’s turn and the drug sailed 16-0 through the committee on the CV risk profile question. The committee also voted that new safety information from the trials be added to the labels of the drugs.
But new diabetes drugs are not yet completely out of danger. In its briefing documents FDA reviewers raised concerns about a possible increase in death with the drugs. Panel members were unable to find any consistency in the data and did not seem concerned, but they did express fears about another looming issue. A consistent signal for heart failure complications– which were not directly studied in SAVOR and EXAMINE– has not been easy to dismiss. Panel members called on the FDA to get companies to study the heart failure question more closely.
The next big event in the field will be the presentation in June of the TECOS trial, a 15,000 patient cardiovascular outcomes trial studying sitagliptin (Januvia, Merck). The results will add a substantial amount of new data about cardiovascular outcomes, including heart failure, with DPP-4 inhibitors.
For now, though, the diabetes drugs appear to have dodged a bullet. But as one panelist observed, there is an important lingering question about these and other diabetes drugs. Without any evidence of cardiovascular benefit, the panelist said, “the diabetes community needs to demonstrate that lowering HbA1c is beneficial.” No one expects a prompt solution to that problem.
Source: Forbes Health
Ad Right Top
Extensive pharmaceutical business and marketing intelligence. If you would like to purchase a back issue, please contact our customer service department at MDAD@kmpsgroup.com, or call 800-869-6882.
February 2015 Focus: Agenda 2015, Top 10 Pipelines, SFE