FDA Approves New Abbott Cholesterol Pill
2 CommentsBy Ed Silverman // December 16th, 2008 // 6:49 am
The drugmakers receives some good news as the FDA endorses the use of TriLipix, which is a new version of the TriCor blockbuster that treats triglycerides, for use both by itself and in combination with statins. To celebrate, Abbott now intends to seek FDA approval next year for a fixed-dose combo pill pairing TriLipix with AstraZeneca’s Crestor.
The move is a boost for Abbott because the TriCor patent doesn’t expire until 2011, giving the drugmaker plenty of time to shift doctors and patients on to the newer drug before lower-cost generics appear. Such a transition may be relatively easy, given that TriCor - a $1.2 billion seller - is not approved for use with statins, such as Crestor or Pfizer’s Lipitor.
Just the same, many docs prescribe TriCor along with statins. Abbott, however, conducted trials showing TriLipix and statins together helped improve levels of triglycerides, LDL and HDL better than the individual meds, although TriLipix has not been shown to prevent heart disease or heart attack (here is the Abbott statement).
By the way, a loyal reader reminds us the drugmaker recently agreed to pay $184 million to settle litigation brought by generic drugmakers, retailers and wholesalers that it tried to keep generic versions of TriCor from becoming available by making minor changes in formulation (back story). The maneuver, which is still the subject of separate lawsuits filed by states attorney general and an investigation by the Federal Trade Commission, would have delayed generics until 2010 or 2011.
Pharmacy Director
Don’t be fooled, all this drug is, is a modified version of a drug that is going off patent in the future. The chemical structure modification imparts no better safety or efficacy that the original drug, Tricor, from what I have read.
The reason why it has the approved use in combination with statins in the label, is likely because its the only fibrate with combination data submitted to the FDA. As mentioned in the article, these drugs have been for the most part safely used in combination for years with statins. Its just that there were no clinical trials submitted to the FDA. And why is that? Well, they are all generic of course. The only brand on the market is Tricor, which is why Abbott has only submitted data to the FDA for its new replacement.
Please don’t forget that Abbott already played patent games with Tricor once in the past. When it originally lost patent and generics became available, Abbott created new brand-only strengths of the drug that would not be available generically until approximately 2010-11.
pharmavet
Since Abbott comarkets Crestor with AZ, and since the new combo contains rosouvastatin, I’m curious how they will pull this off.