Newly Approved HIV Drug Shows Great Promise
AIDS Institute is encouraged with FDA's approval of the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in nearly a decade. TMC125/etravirine was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the U.S. by Tibotec Therapeutics as Intelence, a division of Ortho Biotech Products, L.P. The company announced introductory pricing for the new NNRTI at $21.80 per day, which is substantially lower than other recently introduced antiretrovirals.
In a Title II Community AIDS National Network release dated January 19, 2008, Dr. Donna Christian-Chistensen, Chair of the Congressional Black Caucus Health Brain Trust stated: "The efficacy that Intelence (TMC125/etravirine) has shown in the DUET studies is impressive. Intelence is an important new HIV medication that, for the first time, re-opens the NNRTI class to patients with NNRTI-resistant virus. We applaud Tibotec for its efforts to make this innovative new medication available and accessible to people living with HIV."
The U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti-HIV medication. This is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to an NNRTI and other antiretroviral (ARV) agents. Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment- experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other ARV agents. This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of Intelence. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
Accelerated approval is a regulatory mechanism that allows earlier approval of drugs used to treat serious or life-threatening conditions, based on surrogate endpoints that demonstrate meaningful therapeutic advantage over existing treatment. Accelerated approval is based on evidence of a drug's effect on a surrogate endpoint that reasonably suggests clinical benefit. Accelerated approval requires any necessary studies to establish and define the degree of clinical benefit to patients be completed before traditional approval can be granted.
Dr. Gene Copello, Executive Director of The AIDS Institute, stated: "We appreciate the FDA's accelerated approval process to encourage further research and development of new life-saving medications. Tibotec is to be applauded for this development including the company's attempt to make this new drug accessible."