Abbott Laboratories Submits New Drug Application in the U.S. For Investigational HIV Therapy ABT-378/R
-- Accelerated Approval Sought for Protease Inhibitor --
ABBOTT PARK, Ill., June 1 /PRNewswire/ -- Abbott Laboratories announced today that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market ABT-378/r, also known as
lopinavir/ritonavir, its investigational antiretroviral therapy for HIV and AIDS. Abbott is seeking accelerated approval for ABT-378/r based on ongoing Phase II/III studies evaluating the safety and efficacy of the drug in people living with HIV and/or AIDS. For serious illnesses where patients need access to new medications, the FDA allows accelerated approval based on data from ongoing studies. Full approval is granted based on review of additional safety and efficacy data from Phase III clinical trials. The regulatory submission in Europe is planned for late June and applications for other markets outside the United States
will follow throughout the year.
``Submitting the NDA for ABT-378/r is yet another milestone for Abbott in its long history in HIV care,'' said Arthur Higgins, president, Pharmaceutical Products Division at Abbott. ``ABT-378/r is another example of our continued commitment to discover and develop innovative HIV therapies for those who need viable alternatives.''
Studies of ABT-378/r included as part of the NDA were conducted in both adult and pediatric patients who were either naive or experienced to antiretroviral treatments. These studies evaluated the safety and efficacy of the drug.
Abbott continues the development of ABT-378/r to obtain full FDA approval.
``The submission of ABT-378/r to the FDA for accelerated approval will be welcome news for HIV-treating physicians and people with HIV,'' said Constance A. Benson, M.D., professor of medicine, Division of Infectious Diseases at the University of Colorado Health Sciences Center, and investigator in the ABT-378/r studies. ``We're looking forward to seeing results from Phase III clinical trials of ABT-378/r.''
Abbott has been providing ABT-378/r to patients in markets worldwide since the fall of 1999 through an Early Access
Program. The Early Access Program gives patients who do not have other viable therapeutic options access to this
investigational treatment. Abbott will continue to provide access to ABT-378/r through the Early Access Program while the FDA reviews the NDA.
Abbott Laboratories has been a leader in AIDS research since the early years of the epidemic. In 1985, the company
developed the first licensed test to detect HIV in the blood, and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With ABT-378/r, Abbott has developed two protease inhibitors, and offers nutritional products that meet the unique dietary needs of people living with HIV.
In addition to conducting its own aggressive research to fight HIV and AIDS, Abbott continues its strategic alliance with Triangle Pharmaceuticals to develop and market promising antiviral drug therapies.
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