The world of type 2 diabetes drugs is wacky indeed. While Amylin's long-acting version of Byetta — called Bydureon and predicted by many experts to become a blockbuster — is still held up at FDA, the agency approved a new oral drug earlier this month that is reportedly unremarkable except in the lawsuit it has spurred.
The drug is called linagliptin, brand name Tradjenta, a new oral DPP-4 inhibitor from Eli Lilly and Boehringer that can be combined with other BG-lowering meds, especially metformin.
Upon its release, Amylin promptly filed a lawsuit against Eli Lilly, its partner in developing Bydureon, accusing Lilly of violating federal laws and engaging in anti-competitive practices because "Tradjenta would be a direct competitor for Byetta (exenatide), and Eli Lilly would be able to use the same marketing people on both drugs, giving it the ability to choose which drug is promoted better."
Eli Lilly has denied the charges, stating that Tradjenta will not compete with Byetta, therefore the company "has committed no crime in allying itself with Boehringer Ingelheim." But then yesterday, a U.S. District Court upheld a restraining order banning Lilly from proceeding with its plans to use the same sales force to sell both drugs.
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According to David Kliff of Diabetic Investor, an industry-watcher who knows the in's and out's of the Diabetes Pharma World as well as anyone, "Tradjenta is basically the same drug as Januvia, with some very slight differences... (and) there is no compelling reason for a physician to prescribe Tradjenta over Januvia." He also states that "the vast majority of A1C lowering (effect) 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."
Just a moment there: Januvia competes with Byetta, so of course it stands to reason that Tradjenta will too.
Meanwhile, Januvia also competes with Victoza, another injectable GLP-1 drug from Novo Nordisk, and Onglyza, a once-daily DPP-4 inhibitor pill from Astra Zeneca.
This is confusing as all get-out, if you ask me.
Do the injectables really compete with the oral drugs? And why does it seem that most type 2s are prescribed multiple glucose-lowering medications?
I needed a refresher, so I looked up some of the terms once again and made myself some notes, which will hopefully be useful to you all scratching your heads at home as well:
* DPP-4 inhibitor drugs are taken orally. They lower blood sugar by inhibiting glucagon release, versus...
* GLP-1 receptor drugs (like Byetta), taken by injection. They work to lower your blood sugar in three ways: enhancing insulin secretion, suppressing glucgon release, and gastric emptying.
Who Owns What
- Januvia (Merck) — oral DPP-4, direct competitor to Byetta that is reportedly doing better in the market.
- Janumet (Merck) - a combo of oral drugs Januvia and metformin, designed to help patients cut down on pill-popping. There are other combo drugs in the works, too.
- Victoza (Novo Nordisk) — injectable GLP-1 drug designed to stimulate insulin secretion when hyperglycemia (high blood sugar) is present. Supposedly causes fewer/ less unpleasant side effects than competitors; much-discussed among patients. See our default user forum (721 comments and counting!)
- Onglyza (Astra Zeneca) — a once-daily tablet DPP-4 inhibitor, competes with Januvia; according to some, it's like Januvia but worse.
- Bydureon (Amylin & Lilly) - that GLP-1 long-acting version of Byetta (Amylin) with the potential to be a blockbuster, although studies show it's not as good as Victoza.
What's Different About Tradjenta
It seems the only real differentiator here is the dosing — a single 5mg once-daily to remember for all patients, "regardless of kidney or liver impairment" (not the case with competing drugs).
This is so because Tradjenta, uniquely among DPP-4 drugs, is "not expressed through the kidney but rather through the bile and gut — 95% of it, anyway."
Medical Marketing & Media reports that Tradjenta "has a tough climb ahead of it" because it's coming out third-to-market in its drug class, behind "entrenched category leader" Januvia, which racks up billions in sales.
An "Ideal Diabetes Drug"?
Is there such thing as a single "ideal drug" for type 2 diabetes?
According to Kliff, the famous Dr. Anne Peters of the USC Clinical Diabetes Program recently made this statement:
"My ideal diabetes drug lowers blood glucose, helps reduce weight, improves cardiovascular risk factors, and preserves beta cells — and costs $4 a month."
"Take away the $4 per month cost and what Dr. Peters is describing is actually here today and called a GLP-1. Notice that nowhere in her comments does Dr. Peters mention anything about how this ideal drug would be administered (oral versus injection). ... Although not 'perfect,' a GLP-1 also has additional benefits beyond lowering blood glucose, helping reduce weight, improving cardiovascular risk factors and preserving beta cells."
He also states that "patients can actually see and feel a benefit from using (a GLP-1), something that does not happen with metformin or a DPP-4."
Our Type 2 Friends out there: please share your experiences taking the orals versus injectables. Also, anyone involved in Tradjenta studies or tried this new drug yet?