[Congressional Record (Bound Edition), Volume 154 (2008), Part 1]
[Extensions of Remarks]
[Page 766]
[From the U.S. Government Publishing Office, www.gpo.gov]




                       NEW TREATMENT FOR HIV/AIDS

                                 ______
                                 

                          HON. MARY BONO MACK

                             of california

                    in the house of representatives

                      Wednesday, January 23, 2008

  Mrs. BONO MACK. Madam Speaker, I rise today to celebrate the approval 
of a new treatment that will provide renewed health and hope for people 
living with HIV/AIDS. On Friday, January 18, 2008, the Food and Drug 
Administration approved INTELENCE TM, for the treatment of 
HIV infection. Tibotec Therapeutics innovative efforts in developing 
new, effective treatments for people living with HIV/AIDS should be 
commended.
  We are all aware of the success HIV therapies have had on prolonging 
and enhancing the quality of life for those infected with HIV/AIDS. As 
the infected population lives longer and becomes increasingly resistant 
to current treatment regimens, there is a growing need to focus on 
access to newer therapies for treatment experienced. HIV drug 
manufacturers are being challenged to meet the treatment needs of this 
changing population.
  INTELENCE TM, also known as TMC125, is the first new drug 
in the NNRTI class to be approved in a decade. It brings new hope to 
HIV patients, whose HIV virus has become resistant to other HIV 
therapies, including drugs in the same NNRTI class.
  Tibotec Therapeutics has worked with the HIV patient and physician 
communities in the 45th Congressional district among many others during 
the development and approval of INTELENCE TM. The results of 
these efforts and clinical trials have been positive; patients are 
achieving and maintaining suppressed viral loads with minimal side 
effects. Notably, the FDA approved INTELENCE TM through an 
accelerated approval procedure--a process that is reserved for the 
early approval of drugs that show a meaningful therapeutic advantage 
over existing treatments for serious or life-threatening diseases.
  I applaud the fact that Americans living with HIV/AIDS will now have 
access to a new and important treatment option, affording them the 
possibility of living healthier and productive lives.

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