Will the FDA give Merck a shovel to finish digging its public image out of the Vioxx pit? All set to meet next Wednesday on Merck's proposed HIV drug Isentress (raltegravir), the agency's Antiviral Drugs Advisory Committee released promising info today: Isentress works in patients whose other HIV drugs are no longer effective. The words "highly statistically significant" were used.
The committee will discuss a proposed indication for raltegravir in treatment-experienced patients, in combination with other antiretrovirals. Trials showed that the drug suppressed the virus to undetectable levels, the documents show. The new drug inhibits HIV in an entirely new way, by targeting an enzyme the virus uses to insert its genetic material into human DNA. If it comes to market, it'll be the second novel HIV treatment to be approved this fall; Pfizer won the FDA nod for its Selzentry, or maraviroc, which keeps the virus from entering white blood cells.
- The FDA committee documents are available here
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