Monday, July 07, 2008

AAP Guidelines May Help Extend the Patent Life of Lipitor

Pfizer is searching for a way to maintain the LIPITOR franchise and the American Academy of Pediatrics (AAP) may have just supplied the solution: A new indication for the treatment of high cholesterol in children over 8 years old!

In new guidelines, AAP states: "For children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered" (see AAP press release).

Of course, AAP does not specifically recommend LIPITOR or any other anti-cholesterol drug, but I bet this is giving Pfizer some ideas such as that illustrated here (or perhaps Pfizer gave the AAP the idea to develop new guidelines in the first place?).

Note that few drugs are officially indicated for use in children. Lipitor's label, for example, states "Pharmacokinetic data in the pediatric population are not available."

It is theoretically possible for Pfizer to get extended patent protection for LIPITOR if it ran some clinical trials in children under 12 and if the FDA approved the new indication based on those studies. Hey, it could happen! It's been done before for other drugs.

Sorry Trix rabbit, "Lipitor is for kids, not rabbits -- no yet anyway!"

1 comment:

  1. Anonymous1:51 PM

    This is a common tactic with big pharma- to get a peds indication for thier elderly product for lifespan extension. It is also done with hypertension drugs and others as well. The press around this is sensationalism, as no doctor in thier right mind would start a child on statins.

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