Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for REYATAZ(tm) (atazanavir sulfate), an azapeptide protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. REYATAZ is the first once-daily protease inhibitor approved by the FDA.
"REYATAZ represents a significant step forward in our company's decade-long commitment to finding innovative therapies to combat HIV/AIDS," said Peter R. Dolan, chairman and chief executive officer, Bristol-Myers Squibb Company. "This commitment puts the needs of patients at the center of our efforts to provide the most effective treatments possible. REYATAZ brings unique benefits to people living with HIV/AIDS, including the convenience of once-daily dosing and minimal impact on lipid levels."
The FDA granted a six-month Priority Review for REYATAZ. Pivotal data from Phase II and III clinical trials show that in addition to sustained virologic suppression, REYATAZ, when used in combination therapy, did not significantly increase total cholesterol and triglyceride levels.
"What makes atazanavir distinct is its unique lipid profile -- we have not seen the increased cholesterol and triglyceride levels associated with some other protease inhibitors," said Kathleen Squires, M.D., Associate Professor of Medicine, Keck School of Medicine, University of Southern California. "For HIV patients the approval of atazanavir could be a welcome addition to their drug regimen."
REYATAZ(tm) (atazanavir sulfate) Clinical Trial DataThe FDA submission included data from 15 clinical trials enrolling more than 2,400 people living with HIV. An analysis of pivotal data from Phase II and III trials showed that, in addition to its unique lipid profile, REYATAZ has a distinct resistance profile. The data showed that the signature I50L mutation always developed if resistance to REYATAZ emerged in treatment-naive patients. This signature mutation resulted in a decrease in susceptibility to REYATAZ and an increase in viral susceptibility to other protease inhibitors. In patients on their first regimen, the I50L amino acid substitution may help preserve the use of other protease inhibitors for future treatment.
Results from a Phase III study (AI424-034) showed that REYATAZ + lamivudine + zidovudine (n= 405) provided comparable antiviral efficacy to a standard-of-care regimen containing SUSTIVA(r) (efavirenz) + lamivudine + zidovudine (n=405) in treatment-naive patients after 48 weeks of treatment. An additional Phase III trial (AI424-043) compared a combination regimen containing unboosted REYATAZ 400 mg + two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (n=114) to a combination regimen containing lopinavir boosted with ritonavir + two NRTIs (n=115) in treatment-experienced patients. In this study, antiviral efficacy was demonstrated for both REYATAZ and boosted lopinavir/ritonavir. However, statistically significantly more patients in the boosted lopinavir/ritonavir treatment arm achieved virologic suppression at 24 weeks. The study also demonstrated that the regimen containing REYATAZ resulted in a decrease in LDL-cholesterol, total cholesterol and triglycerides from baseline (-6%, -2% and -2%, respectively), while the boosted lopinavir/ritonavir arm resulted in an increase in LDL-cholesterol, total cholesterol and triglycerides from baseline (+5%, +17% and +55%, respectively).
The recommended dose of REYATAZ is 400 mg (two 200 mg capsules) taken once a day with food in combination with other antiretroviral medications. It will be available in 100 mg, 150 mg and 200 mg capsules. For more information, please see full prescribing information at www.reyataz.com.
REYATAZ(tm) (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Do not take REYATAZ if you are taking the following medicines: ergot derivatives, Versed(r), Halcion(r), Orap(r), Propulsid(r), Camptosar(r), Vascor(r), Crixivan(r), Mevacor(r), Zocor(r), Rifampin, St. John's wort, AcipHex(r), Nexium(r), Prevacid(r), Prilosec(r) or Protonix(r). Do not use Viagra(r) while you are taking REYATAZ without first speaking with your healthcare provider. Discuss all prescription, non-prescription and herbal products you are taking or plan to take with your healthcare provider.
Increases in indirect bilirubin (bilirubin is made by the liver) have been reported in patients taking REYATAZ. This may result in yellowing of the skin and/or eyes. These symptoms usually go away after you stop taking REYATAZ.
Changes in the way your heart beats may occur when taking REYATAZ. If you get dizzy or lightheaded these could be symptoms of a heart problem. An increase of lactic acid in the blood (lactic acidosis), which can cause death, has been reported in patients taking REYATAZ with other anti-HIV medicines called nucleoside analogues. In some patients taking protease inhibitors, increased bleeding (in patients with hemophilia), diabetes and high blood sugar have occurred. If you have liver disease, including hepatitis B or C, your liver disease may get worse when you take anti-HIV medicines like REYATAZ.
Changes in body fat have been seen in some patients taking antiretroviral therapy. The cause and long-term effects are not known at this time. Frequent side effects reported in REYATAZ containing regimens include: nausea, headache, rash, abdominal pain, vomiting, diarrhea, tingling in hands or feet, and depression.
REYATAZ does not cure HIV or prevent passing HIV to others.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
REYATAZ(tm) is a trademark of Bristol-Myers Squibb Company.
SUSTIVA(r) is a registered trademark of Bristol-Myers Squibb Pharma Company.
The other brands listed are registered trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.
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