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WASHINGTON, Oct. 16 (UPI) -- The U.S. Food and Drug Administration announced approval Tuesday of raltegravir tablets for treatment of the human immunodeficiency virus.
The FDA said the drug was approved for use "in combination with other anti-retroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple anti-retroviral agents."
Officials said raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors that are designed to interfere with the enzyme that HIV-1 needs to multiply.
"This is an important new product for many HIV-infected patients whose infections are not being controlled by currently available medications," said Dr. Janet Woodcock, the FD A's deputy commissioner for scientific and medical programs.
The FDA said the long-term effects of raltegravir are not yet known, and its safety and effectiveness for pregnant women and in children younger than 16 years has not been studied.
Raltegravir is sold under the brand name Isentress and is distributed by Merck & Co. Inc.
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