Diabetes Drug Labels Should Reflect Heart Failure Risk, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Advisory committee endorses CV ischemic safety of AstraZeneca’s saxagliptin and Takeda’s alogliptin but recommends safety-related revisions to the labels of both DPP-4 inhibitors.
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Merck got a complete response letter from FDA on a cardiovascular risk-reduction claim for the DPP-4 inhibitor based on TECOS trial data. This places Januvia/Janumet behind Jardiance, which already has a CV safety label claim, and Victoza, which awaits an FDA decision on a supplemental NDA filed last October.
Keeping Track: Teva's Austedo Clears US FDA, Merck Sitagliptin CV Outcomes Labeling Draws Complete Response
The latest drug development news and highlights from our FDA Performance Tracker.
Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.