Two weeks ago, I wrote about AZ & BMS's new diabetes drug, dapaglifizon. Looking at the data, I had my concerns about the drug and its links to cancer, increased infections, and increased renal stress and liver stress.
The drug had it review on July 19. By 9 to 6 votes, the panel rejected the drug over liver and cancer concerns. This was to be the first drug in this new class of SGLT2 inhibitors that removes glucose by moving it through the kidneys and then through urine.
It will be interesting to see what happens with similar drugs from Lilly, J&J, Astellas and Boehringer Ingelheim. Will they have time to ensure they have different data? Can they have different data?
I have to say I was not excited about this new class when I first read about it. I understand it would be once a day dosing and doesn't seem to impede weight loss - these are big positive for patients especially the weight loss.
But the risks of some of the newest classes of drugs are high. And we have just begun to see problems with DPP IV's which I predict will increase.
The FDA may send dapagliflozin back for more trials. But for me, efficacy would have to be tremendous and physicians would have to really screen who gets the drug, for the risks to be worth it.
Wool Labs is working to develop Phase IV/V programs to look at safety and efficacy of products through the lens of how patients report performance and experience. We already work with clients as well as publish our own research on how patients discuss their diseases and conditions, medication, and safety and efficacy measures. So the point to this blog is to explore this concept further.
Thanks for the head's up. If this class does not fly there's going to be a fair amount of teeth-gnashing amongst folks sorta kinda expecting the business!
ReplyDeleteYes, I agree. Also efficacy seems reduced when the kidneys are damaged, which makes sense since this drug relies on the kidneys to get the glucose to urine. So that's another problem for two reasons.
ReplyDeleteFirst, alot of diabetes patients have impaired kidneys anyway and second, I would think this drug would increase renal stress just simply because of how it works.
So to me, the prognosis of a drug that works the way this class does seem good long-term. Does it burn out a patient's kidneys after they have been on it for a long time?
Anyway, we might not ever know as the Goldman Sach is reporting to investors that they don't think that the other drugs from J&J, Lilly and BI will approved or if they are, their use will be limited.
At some point pharma is going to have to do a better job in patient stratification to get new drugs approved. These type of drugs do not belong blanketing the entire diabetes community.