Januvia approved
You’ve probably read that Januvia, Merck’s DPP-IV inhibitor for type 2 diabetes was approved today as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood glucose control in patients with type 2 diabetes when diet and exercise is not enough.
I’ll have a look at the label and FDA reviews for Januvia as soon as I can, focusing on the evidence Merck presented to assure FDA that Januvia is safe in a broad diabetic population. I’m already convinced that it is effective in relatively early diabetes and has the exciting potential to slow the progressive beta cell failure that is a hallmark of the disease.
As far as safety, you’ll recall that DPP-IV is a coactivator of T cells and is involved in metabolism of a number of peptides, so there is a theoretical safety issue with inhibiting it with a drug like Januvia. Given that FDA’s DMEDP didn’t ask for advice from its advisory committee, I’m assuming that there were no safety signals to speak of. If the safety evidence in the reviews and label is compelling, I see no reason other than cost (~$5/day) not to try Januvia as first-line therapy. Cost will likely keep Januvia off many Tier 1 (low co-pay) formularies for monotherapy, where both generic and branded forms of metformin are cheaper. That said, there’s a very large potential patient base for this product in monotherapy and combination therapy, and I expect its uptake to be robust, better than the uptake of Avandia when it was first launched.
Congratulations are due to Merck. Well done.
Fredric Cohen said,
October 17, 2006 at 2:05 pm
Update on the label: I’ve read through the label. Januvia has a very clean clinical and preclinical toxicity profile based on labeling alone. Its drug interaction potential is low and no dosage reduction is required except in moderate to sever renal impairment. There were no clues in the label regarding investigations to rule out pleiotrophic activity at DDP-IV that might be subclinical in the studies reported in the label but could still be clinically meaningful in a larger, more diverse treatment population. Until such time as this information is made publicly available I advise caution before prescribing Januvia to those at particular risk of adverse effects due to mild suppression of T-cell immunity (i.e. those who are already immunosuppressed for whatever reason).