http://www.fiercebiotech.com/fda-frets-over-safety-sanofi-s-diabetes-combo
Citando:
"The FDA has set up a debate among outside experts over Sanofi’s ($SNY) combo diabetes drug LixiLan today by raising a series of red flags over potential safety issues that could arise if the combination is allowed to reach the market.
In particular, regulatory insiders say that Sanofi’s proposed dose range for the combo, a mix of Lantus and lixisenatide--now dubbed "iGlarLixi"--would likely create some confusion over dosing among physicians, as well as expose some patient groups to adverse risks. The regulator's docs also noted the clear possibility that the final trial data were biased by inadequate dosing of insulin.
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