Pfizer Nears HIV Drug Approval  E-mail

This week Pfizer announced that they will be applying later this year to the FDA for approval on a new class of HIV/AIDS drugs.

The drug is called Maraviroc and it doesn’t target HIV specifically, it blocks the virus from infecting healthy cells.

Maraviroc belongs to a new class of HIV/AIDS drugs called CCR5 entry inhibitors, which are able to change the body’s immune system.

Human cells have locks on their surface called receptors in which a virus must insert a key to gain entry.  HIV most often uses the CCR5 receptor to gain entry to cells.  It then transforms those cells into virus-producing factories that can make up to 1 million copies a day.  CCR5 entry inhibitors are designed to block the doorway HIV uses to enter healthy cells, preventing them from replicating.

Maraviroc is in the final stages of clinical tests and they are going to try and file for registration before the end of 2006.  It is estimated that a drug of this type would generate about $750 million dollars in sales after only four years on the market.

Pfizer is developing a similar drug with Schering-Plough called Vicriviroc.  They believe that it’s very potent, safe and would only have to be taken once a day.  It would still be used with existing antiretrovirals as part of a multi-drug plan.

While this may seem like good news, there are still many unanswered questions.  Researchers still don’t know the long-term health effects of CCR5 inhibitors, which have been linked to liver problems and cancer.

Many HIV/AIDS patients are in need of new treatments because HIV is becoming more resistant to the existing FDA-approved drugs used to treat HIV.

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