Another new diabetes drug bites the dust
Based on the announcement made by Bristol Myers Squib (NYSE:BMY) and AstraZeneca (NYSE:AZN) regarding the change in the PUDFA date for dapagliflozin, which has been pushed back until January 28th 2012, it looks like that date could well go done as milestone date in diabetes as that’s the same date the FDA is supposed to deliver a decision on Bydureon. Other than the same PUDFA these two drugs have very different outlook should the FDA approve either or both drugs.
According to a press release issued yesterday; “In response to an FDA request for additional data on dapagliflozin, Bristol-Myers Squibb and AstraZeneca are submitting data from recently completed and ongoing Phase 3 clinical trials. This data submission constitutes a major amendment to the original new drug application (NDA) for dapagliflozin.” Based on published reports the main issues hanging over dapagliflozin are breast and bladder cancer concerns. Given the FDA’s heightened attention to adverse event profiles for new diabetes drugs, Diabetic Investor pegs the chance of dapagliflozin getting a clean approval at less than 50/50 and there is a strong possibility the agency could decline the drug outright.
It’s important to note that dapagliflozin is from a new class of diabetes agents called SGLT2-inhibitors that work by letting patients excrete excess blood sugar in their urine. Additionally the drug is the first SGLT2-inhibitor to be submitted to the FDA. When you add it all up the outlook is less than promising even if the FDA approves the drug.
Since you can’t swing a dead cat in this business without hitting another company that also has a SGLT2 under development the FDA’s decision will obviously impact more than Bristol and Astra. No matter what the decision, Diabetic Investor suspects the drug would have a very tough time establishing itself in the market. The harsh reality when it comes to new diabetes drugs especially new drugs that come from an entirely new class of drugs, they must not only be better than known drugs but come to market with a clean adverse event profile. Given what happened with Avandia and what is now happening with Actos, physicians are in no mood to experiment with an unknown commodity that may or may not have issues down the road. As the old saying goes better to go with the devil you know rather than one you don’t.
This is in sharp contrast to the environment Bydureon will face. While there are some issues with the drug, these issues are well known and physicians are becoming increasingly comfortable with the GLP-1 class of drugs, something that was reinforced again today when Novo Nordisk (NYSE:NVO) reported results this morning where sales of their GLP-1 Victoza® continues to do well.
It’s also in sharp contrast to the drugs dapagliflozin will be competing against, Januvia being the biggest competitor. Unlike dapagliflozin the issues known to Januvia developed after the drug hit the market and so far and not serious enough to warrant physicians from changing a patient’s therapy regimen. Even if a physician was considering replacing Januvia, it’s unlikely they would chose dapagliflozin and more likely they would move to a GLP-1 or insulin. They could even change form Januvia to another DPP4 sold by Bristol, Onglyza.
Looking over all the evidence it’s looking more and more like it really won’t matter what the FDA decides dapagliflozin is yet another new diabetes drug that is dead before it even arrives on the market. So say so long to dapagliflozin, it’s too bad we never had a chance to get to know you better, but then again maybe not. The last thing anyone needs is another drug approved by the FDA that turns out to have some serious issues develop down the road. As we have seen with Avandia and Actos, been there, done that.