DisforDiabetes: Another Me-Too Diabetes Drug

Another Me-Too Diabetes Drug (April 18, 2014)

In the field of pharmaceutical medicine, drugs that are the second in their class of medications are frequently called "me-too" (or "me-two") drugs. But what do you call the third and fourth drugs in the same class? Copycats? Hitchhikers? Wishful thinking?

Well, it's happening again: another diabetes drug has been approved by the FDA, and hailed by the manufacturer's press release as "an effective new weekly GLP-1 treatment option." That's about all they can say -- it's the fourth chemically-similar compound in the class of medications called GLP-1 agonists* to be approved by health authorities. Oh, and the second that's approved for weekly use**. And of course it's effective -- if it were ineffective, it wouldn't have been approved!

Why do manufacturers push another drug in the same class where another company already has the market to themselves? I guess it's like a second or third brand of English muffins, or of automobiles or wide-body jets: there's the perception that the market is big enough to share some of the profits amongst competing companies.

The first-to-market usually enjoys lasting name recognition: I still think of the brand name "Inderal" when I think of beta-blockers. And I think of Kleenex. And Xerox. And... That's especially true when the names of the competitors don't make any sense, and were probably generated by a random-word generator before being market-tested to be sure they don't have any unexpected negative connotations somewhere in the world.

It's not that the second (or third or fourth) drug in the class is likely to be any different from the others. Sometimes there is a difference (once daily vs twice daily administration, or with the GLP-1 agonists, daily vs. weekly). Sometimes there's a difference in pricing (especially if there's a generic on the market and the brand name drugs try to pitch their products as better than the generic). And sometimes there's a difference in side-effect profiles.

And of course, whenever there's a new drug, there's another set of bizarre drug names to try to remember -- which I suspect is designed to drive the prescribing physician crazy. In the present case,
the new medication is named Tanzeum (what in the world were the marketers thinking? I can't find anything close on a Google search, except the German phrase "Ich tanze um die Welt mit dir" -- which translates to "I dance around the world with you"). Oh, you'd prefer the generic name? It's albiglutide. Or a third name for the same stuff? How about Eperzan -- that's the name the manufacturer is using for the same stuff when selling it in Europe.

Back to the press release. On the positive side, there's the fact that Tanzeum is effective, and that it's weekly.

The negative side is lengthy. As the press flacks point out, it's not suitable for initial therapy. And not studied with pre-existing pancreatitis, GI disease, nor in combination with mealtime insulin. And is not recommenended for T1DM or DKA. And might cause thyroid C-cell tumors including carcinoma. Or pancreatitis. Or hypoglycemia. Or hypersensitivity reactions. Etc. And the press release mentions that the FDA is sufficiently worried that they are insisting on "a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis." Not mentioned in the press release: "The FDA is requiring the following post-marketing studies for Tanzeum:

a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;

a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;

a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease."

Also not mentioned in the press release: The manufacturer hasn't studied it in pregnancy. Nor in kids under 18.

These safety issues are similar to those known throughout the entire class of GLP-1 drugs. It seems unlikely that the safety profile of this new entry into the diabetes arena will be any different from the other GLP-1 agonists. Or that it will be more effective.

Ho-hum. Looks like just another me-too drug.

* The others are Byetta, AKA exenatide; Victoza, AKA liraglutide; and Bydureon/exenatide extended-release. Also, in Europe, there's Lyxumia, AKA lixisenatide (it's still pending approval in the US).
** The first once-weekly GLP-1 agonist was Bydureon brand of exenatide.