FDA Update on Vytorin/Zetia, Issued Today

Despite what some of the ill-informed members of the fourth estate are writing at the moment ("FDA says Vytorin works" -- sheesh -- do read, for content!) -- this doesn't "clear" Vytorin/Zetia, in any sense -- it only says that FDA feels it is not "unsafe". Not a big thing, really.

Second, the real focus of the FDA announcement is to keep people taking their cholesterol meds -- regardless of brand -- until they talk to their doctors about treatment options. This is no "clean bill of health" for Vytorin, or Zetia.

It is not a death sentence, either, though. That will come, via one thousand papercuts, from the third-party payers -- death by (increasingly accelerating) co-pays, and dropping reimbursement levels -- in 2009, vis-a-vis ordinary, old generic statins.

So, pending the results from IMPROVE-IT (not due out, now, until late 2012), all FDA said today was that patients should not stop taking Vytorin or other cholesterol lowering medications -- but should talk to their doctor -- if they have any questions about these medications. Yep, that's all the FDA said today. This FDA update, by its terms, relates only to safety, not to comparative efficacy (measured by relative risk-rates for CV events), however.

FDA Issues Update to Safety Review on Cholesterol-Lowering Drugs

The U.S. Food and Drug Administration today reaffirmed its position that elevated amounts of low-density lipoprotein (LDL), or “bad cholesterol,” are a risk factor for cardiovascular diseases such as heart attack, stroke and sudden death and that lowering LDL cholesterol reduces the risk of these diseases.

FDA’s comments are contained in an update to its Jan. 25, 2008, Early Communication describing the agency’s review of data from ENHANCE, a clinical trial comparing Zocor (simvastatin), a drug that lowers cholesterol production in the liver, to Vytorin, a drug that combines Zocor with another drug, Zetia (ezemtimibe), which inhibits cholesterol absorption.

Preliminary results from ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) had indicated there was no significant difference between Vytorin and Zocor-treated patients in the thickness of the walls of the blood vessels of the neck (the carotid arteries) although there was greater lowering of the amount of LDL cholesterol in patients with Vytorin compared to Zocor.

Measuring the thickness of the carotid arteries via ultrasound imaging is considered a biomarker of risk for cardiovascular disease.

FDA has now completed its review of the final clinical trial report of ENHANCE. After two years of treatment, there was no significant difference in carotid artery thickness between Vytorin patients and Zocor patients. However, the levels of LDL cholesterol, decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group.

The results from ENHANCE do not change FDA’s position on the benefits of lowering LDL cholesterol. Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions about Vytorin, Zetia or the ENHANCE trial.

FDA’s Early Communications are disclosures that the agency has begun evaluating new data about a drug and is considering regulatory action, but has yet to reach a conclusion. . . . .

Later, per a pull-quote from a commenter, below, in the Linda Johnson AP story on this: . . . ."The price differential between the two products [Vytorin/Zetia v. statins] is so big that this may not make much of a difference" in sales of Vytorin and Zetia, given the recession, said analyst Steve Brozak of WBB Securities. . . .

EVEN LATER (01.09.09 -- $18.30 NYSE Close): "I told ya' so!"