Sanofi, ORIGIN TRIAL – No Implications, but removes the cancer risk overhang
The ORIGIN trial was intended to expand Lantus use in the pre / early diabetes patient with high CV risk, which were a high hurdle and a failure to demonstrate CV outcome benefit in this patient setting will not have implication on its existing use in the late stage setting. In the trial, Lantus did delay the progression of pre-diabetes to diabetes, but a label expansion on this ground is unlikely as this did not translate into outcome benefit, and came at a cost of significantly higher rates of hypoglycemia, weight gain and compliance disadvantage. The only positive implication for Lantus from the ORIGIN trial is that it completely removes the cancer risk overhang on Lantus as in the trial there was no imbalance in the cancer events across the two arms.
COMPANIES MENTIONED
Sanofi
Sanofi