Disturbia: FDA's Sneak Attack on Maraviroc

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  • 04/23/2007
AP's Andrew Bridges reports today that

" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.

Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.

Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.

The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."

Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?

A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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