Isentress Approval Expanded to Include Children and Teens
The drug is an integrase strand transfer inhibitor that helps slow the spread of the AIDS-causing virus throughout the body, the agency said in a news release. It was first approved for adults in October 2007.
The twice-daily pill is available in a chewable form for people aged 2 to 11, and in non-chewable form. Clinical testing of the drug among 96 children and teens with HIV-1 infection showed 53 percent of patients had undetectable blood HIV levels after 24 weeks, the FDA said.
The most common reported side effects of Isentress included trouble sleeping and headache.
The drug does not cure HIV infection, and patients must take Isentress continually to ensure ongoing reduction in HIV-related illness, the FDA stressed.
The drug is produced by Merck & Co., based in Whitehouse Station, N.J.
The U.S. Department of Health and Human Services has more about HIV/AIDS.
Posted: December 2011