December 22, 2011
SILVER SPRING, MARYLAND (BNO NEWS) — The U.S. Food and Drug Administration (FDA) on Wednesday announced that it has approved Isentress (raltegravir) for use with other antiretroviral drugs for the treatment of HIV-1 infection in children and adolescents.
Isentress works by slowing the spread of HIV in the body and is part of a class of medications called HIV integrase strand transfer inhibitors. Under the FDA’s accelerated approval program, the drug was first approved for use in adult patients in October 2007. Children and adolescents from 2 to 18 years old will now be able to take the medication.
The FDA’s accelerated approval program allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.
The program is also designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug’s clinical benefit.
“Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
A single, multi-center clinical trial of 96 children and adolescents ages 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.
The FDA said the most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping (insomnia) and headache. However, the frequency of these side effects is similar for children and adults.
One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash. The drug should be discontinued if this occurs.
The agency underlined that Isentress does not cure HIV infection, and patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.