The FDA Actually Does Approve New Diabetes Drugs
Although it seems as if the FDA is continually looking for reasons not to approve new treatment options for patients with diabetes, occasionally there is an exception to every rule. Late this afternoon the FDA Tradjenta™, a DPP-4 inhibitor from Lilly (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals. According to Lilly’s press release; “TRADJENTA belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With TRADJENTA, no dose adjustment is recommended for patients with kidney or liver impairment.”
The release also states; “TRADJENTA can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo).”
Now Diabetic Investor does not want to appear ungrateful and we are in somewhat of a state of shock that contrary to prevailing beliefs, the FDA actually does on rear occasions approve new treatments for diabetes, but why is it they always approve new medications that are basically a knock off of an existing medication that’s already on the market. While the folks at Lilly and Boehringer will beg to differ Tradjenta is basically the same drug as Januvia®, with some very slight differences. It is these slight differences that Lilly and Boehringer will attempt to exploit when marketing the drug. Yet when looking at the data comparing Januvia, which holds a dominate market share and Tradjenta, what you have nearly mirror images of each other. Or put simply, unless a patient falls into a narrow spectrum, there is no compelling reason for a physician to prescribe Tradjenta over Januvia.
The reality is Diabetic Investor has yet to find any DPP-4 inhibitor that does much good when used as a monotherapy. Looking back at the Januvia study data basically what you see is the vast majority of A1C lowering comes when Januvia is used in combination with metformin, take away the metformin and you have a rather lackluster drug with a suspect safety profile. Initially promoted as safe alternative to Avandia, Januvia has undergone changes to its label as concerns were raised over its safety profile. Given the track record of this drug class, Diabetic Investor doesn’t believe Lilly and Boehringer will be overly promoting safety profile and if they do they could be in for rude awakening.
Still this approval does offer hope to Lilly in another area as it shows the FDA is not averse to approving new drugs which gives them hope for drugs that actually work very well, like Bydureon.
Although today’s decision had nothing to do with diabetes devices, this group of companies can take a small measure of comfort in the fact the FDA is actually working and not just sitting around looking for more obstacles to throw in the way of companies in the business of diabetes.
Even though Diabetic Investor isn’t all that impressed with Tradjenta let’s chalk one up in the win column and hope this is a sign of good things to come. Let’s hope that the FDA realizes there is no such thing as “perfect” diabetes drug and that given the epidemic growth rate of diabetes patients need more, not less, treatment options. Let us also hope the FDA has moved forward in the device area as well and understands that patients with diabetes are not like heroin addicts who commonly share their needles. Finally let us hope, more like pray, that the FDA is done standing in the way of progress, turning America into a third world country when it comes to drugs and devices, increasing development costs with unnecessarily regulations, requiring useless studies that will do nothing more than slow down the approval process and has awakened to the fact unless they act and act now the diabetes crisis in this country will go from bad to worse.