The drug is part of a class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. It was first approved for use in adult patients in October 2007, under FDA's accelerated approval program, which 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 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, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
Isentress is a pill that can be taken twice daily, with or without food. The pill is also available in a chewable form. Because the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.
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 most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping (insomnia) and headache. 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.
Isentress does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.
Isentress is made by Whitehouse Station, N.J.-based Merck & Co., Inc.
SOURCE U.S. Food and Drug Administration