The US Food and Drug Administration (FDA) has granted accelerated approval to the anti-HIV medication Intelence (etravirine) tablets -- the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to a NNRTI and other antiretroviral (ARV) agents.
Intelence, also known as TMC125, was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the US by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.
"NNRTIs have been used in HIV combination therapy for more than a decade, but their use has been limited by cross-resistance within the class. Resistance to one NNRTI generally meant resistance to all NNRTIs," said Richard Haubrich, M.D., Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and investigator in the Intelence Phase 3 DUET studies. "Etravirine breaks new ground in the NNRTI class, and provides a new option to thousands of treatment-experienced patients with NNRTI-resistant HIV."
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 a 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.
The following points should be considered when initiating therapy with Intelence: Treatment history and, when available, resistance testing, should guide the use of Intelence; The use of other active antiretroviral agents with Intelence is associated with an increased likelihood of treatment response; In patients who have experienced virologic failure on a NNRTI-containing regimen, do not use Intelence in combination with only N[t]RTIs; The risks and benefits of Intelence have not been established in paediatric patients or in treatment-naïve adult patients.
FDA accelerated approval procedures allow for earlier approval of drugs that provide a meaningful therapeutic benefit over existing treatment for serious or life-threatening diseases. The Intelence approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the DUET-1 and -2 studies. Longer-term data will be required before the FDA can consider traditional approval for Intelence.
"It is very inspiring to our R&D organization to see an additional compound so quickly emerge from our pipeline and reach patients who need it," said Roger Pomerantz, M.D., FACP, President, Tibotec Research and Development. "With one of the most robust virology research and development programs in the industry, we are dedicated to continuing to deliver innovative approaches in HIV management in the years to come."
"The addition of Intelence following the launch of our first antiretroviral just two years ago is a significant milestone for Tibotec Therapeutics," said Glenn Mattes, President, Tibotec Therapeutics. "In partnership with Tibotec R&D, we are committed to continuing to bring new options to people living with HIV."
Intelence is the first new NNRTI to be introduced in nearly 10 years. It is also the first NNRTI to show antiviral activity in patients with NNRTI-resistant virus. NNRTIs block reverse transcriptase, a key enzyme the HIV virus uses to replicate. NNRTI drug resistance occurs when HIV develops mutations that partially or completely stop the NNRTI from binding to the reverse transcriptase enzyme, causing the drug to lose effectiveness. As with other HIV medications, patients can develop resistance to Intelence.
According to a company press release, Intelence is expected to be available at the wholesale level in the US within one week.
Martin Delaney of the Fair Pricing Coalition said, "Tibotec Therapeutics continues to demonstrate real leadership in the pharmaceutical industry by pricing Intelence fairly and responsibly. We applaud Tibotec's responsible corporate behaviour and expect to see the drug quickly accepted on all formularies."
"With the introduction of Intelence, Tibotec Therapeutics has demonstrated exceptional leadership in working with the HIV community in an effort to address pricing and access issues. Tibotec has repeatedly recognized the necessity of responsibly pricing HIV products and should be commended for its leadership in this regard," said Lynda Dee from the AIDS Treatment Activist Coalition.
Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.