Abbott Laboratories Gains FDA Approval For HIV Treatment Kaletra(TM) (Lopinavir/Ritonavir), Formerly Known as ABT-378/r
Phase II/III Studies Across a Spectrum of HIV Patients Support Accelerated Approval
ABBOTT PARK, Ill., Sept. 15 /PRNewswire/ -- Abbott Laboratories (NYSE: ABT - news) announced today it received
accelerated U.S. Food and Drug Administration (FDA) approval to market its antiretroviral, Kaletra(TM) klopinavir/ritonavir) (pronounced Kuh-LEE-Tra), formerly known as ABT-378/r, for the treatment of HIV infection in adults and children six months and older in combination with other antiretroviral medications. The approval of Kaletra follows extensive work by Abbott scientists to design a protease inhibitor for patients who are new to, as well as those experienced with, HIV therapy.
For serious illnesses where patients need access to new medications, the FDA allows accelerated approval based on data from ongoing studies. Accelerated approval of Kaletra is based on the response of viral load (amount of virus in the blood) measurements and CD4 cell count, both surrogate markers, from a 24-week controlled Phase III clinical trial and additional smaller open-label studies of 72 weeks in duration. The 72-week studies were designed to evaluate different doses of Kaletra and had no comparator groups. At present, there are no results from controlled trials evaluating the effect of Kaletra on the progression of HIV. Full approval is granted based on review of additional safety and efficacy data from Phase III clinical trials.
Kaletra will be available in capsule and liquid formulations in pharmacies nationwide within the next week. Kaletra is the only protease inhibitor approved for use in children as young as six months. Regulatory submissions outside the United States have already begun and will continue through the remainder of the year.
Phase III Clinical Trial Results
In the first reported double-blind, ongoing pivotal clinical trial comparing two protease inhibitors in 653 patients new to antiretroviral therapy (study M98-863), Kaletra in combination with stavudine (d4T) and lamivudine (3TC) reduced the HIV RNA, or viral load to below detectable levels (less than 400 copies/mL) in 79 percent of patients compared to 70 percent of patients on the combination of nelfinavir, d4T and 3TC. This difference between the Kaletra and nelfinavir treatment groups was statistically significant. These data were evaluated using an intent-to-treat (ITT) analysis, which captures data on all study participants, including those who left the study early for any reason and were considered treatment failures. Through 24 weeks,only two percent of patients discontinued from each treatment group due to study drug-related side effects. The total discontinuation rate was 14 percent for the Kaletra treatment group and 12 percent for the nelfinavir treatment group.
An additional analysis conducted on data from the Phase III study comparing Kaletra to nelfinavir included patients who remained on treatment (OT). OT analysis captures data for patients who remained on treatment and had results at a particular timepoint, therefore results from OT analyses are typically higher than results from ITT analyses. Using the OT analysis, at 24 weeks, 92 percent of patients taking the Kaletra regimen were suppressed to below detectable levels (less than 400 copies/mL) compared to 81 percent of patients taking the nelfinavir regimen.
``This study is supported by promising data we've seen in additional open- label clinical trials among patients new and experienced with HIV therapy,'' said Joel E. Gallant, M.D., M.P.H., associate professor of medicine and director of the Moore HIV Clinic at Johns Hopkins University School of Medicine. ``Because of impressive antiviral response, Kaletra may prove to be an important addition to our HIV-drug arsenal.''
Additional Phase II/III open-label studies of Kaletra in combination with other antiretrovirals in both treatment-naive and PI-experienced patients show Kaletra maintained viral suppression through 72 weeks. In an ongoing Phase II study of naive and experienced children six months of age and older, Kaletra maintained viral suppression through 24 weeks.
Kaletra should not be used with certain medications. Taking certain other drugs with Kaletra could create the potential for serious side effects that could be life threatening. Patients should always talk to their physician or healthcare provider before starting new medicines. Kaletra should not be taken if a patient has had an allergic reaction to Kaletra or any of its ingredients.
Cross resistance has been observed
Increased bleeding in patients with hemophilia, and diabetes and high blood sugar have occurred in some patients when taking protease inhibitors. Changes in body fat have been seen in some patients receiving antiretroviral therapy. Some patients receiving Kaletra have had increases in triglycerides and cholesterol. Pancreatitis and abnormal liver function have been reported in patients receiving Kaletra.
Kaletra is not a cure for HIV infection. People treated with Kaletra may continue to acquire illnesses associated with advanced HIV infection, including opportunistic infections. Kaletra has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Patients should continue to practice safe sex and should not use or share dirty needles. The most commonly reported Kaletra-related side effects of moderate severity are: abdominal pain, abnormal stools, diarrhea, feeling weak/tired, headache, nausea and vomiting.
Kaletra should be given with a patient's choice of food twice daily to adults usually in either three capsules or a 5 mL liquid formulation (400/100 mg). The dose for children six months to 12 years is based on weight. Patients do not need to refrigerate Kaletra if used within two months and stored below 77 degrees F. Pharmacies should store Kaletra at 36 degrees F - 46 degrees F until dispensed.
`The FDA approval of Kaletra further demonstrates Abbott's strong commitment to HIV care,'' said Arthur J. Higgins, president, Pharmaceutical Products Division, Abbott Laboratories. ``For the second time in just over four years, we are pleased to provide a new option in HIV treatment and we are excited about making Kaletra available to patients.''
Since fall 1999, Abbott has been providing Kaletra to patients worldwide through an Early Access Program. The Early Access Program gives patients who do not have other viable treatment options access to this treatment. Abbott will continue to provide Kaletra to patients who participated in the program during a two-month period while they obtain coverage for the medication.
Abbott Laboratories has been a leader in HIV/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 the leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. With Kaletra, Abbott has developed two protease inhibitors. The company also offers nutritional products like Ensure® 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.
AMEN BROTHER!
Fantastic news for those with the disease...And I know many.
It's really a great drug.
SO much for the big boys being dead!
This company has a LOT going for it and it UNDERvalued and has been banging it's head on 45 for MONTHS.
chris |
