Expanded Indication for Epivir(R) - The Most Widely Prescribed
Antiretroviral - Epivir Proven Potent and Safe Across Wide Range of
Multiple Drug Regimens
LAVAL, Quebec, March 24 /CNW/ - BioChem Pharma Inc. (NASDAQ: BCHE; ME, TSE: BCH) today announced that the U.S. Food and Drug Administration granted approval for expanded prescribing information on the use of Epivir(R) (lamivudine), also known as 3TC(R), in infants, children, and adolescents. In addition, this approval also includes an important revision to the indication for use of Epivir in combination with other antiretroviral agents for the treatment of HIV infection in adults and children. This broad indication reflects the demonstrated safety and efficacy of Epivir, a nucleoside analogue reverse transcriptase inhibitor (RTI), in numerous clinical studies since 1991. Epivir Tablets and Oral Solution have been a key component of successful combination therapies in patients with HIV infection. Epivir products are the world's most widely prescribed antiretroviral drug, and in the U.S., are part of combination therapy for nearly 75% of patients receiving treatment. Epivir originally received accelerated approval for use in combination with Retrovir(R) (zidovudine, AZT) for the treatment of HIV on November 17, 1995.
''This new indication recognizes the central position Epivir plays in the battle against HIV in both pediatric and adult patients,'' said Lynn Smiley, M.D., vice president, HIV and Opportunistic Infections Clinical Development at Glaxo Wellcome. ''Potent antiviral effect, proven safety, and ease of use make Epivir an integral part of the multi-drug combination regimens taken by most patients with HIV.''
Combination therapy with Epivir has been proven to prevent AIDS-related infections and prolong life in several landmark HIV studies, including ACTG 320 and the CAESAR trial. The CAESAR study was the basis for traditional approval of Epivir in the U.S. in April 1997. This new approval expands the FDA-approved pediatric information to include patients from three months to 16 years of age. Since the original approval in 1995, Epivir has been used safely in combination with many other antiretroviral agents, and was part of the pivotal clinical trials used as part of the basis of approval of four other HIV therapies: the nucleoside analogue RTI Ziagen(TM) (abacavir sulfate), the non-nucleoside RTI efavirenz, and the protease inhibitors indinavir and nelfinavir.
Glaxo Wellcome submitted supplements to the NDAs for Epivir Tablets and Epivir Oral Solution that provided the FDA with reports of three pediatric studies (ACTG 300, NUCA2002, and NUCA2005). The ACTG 300 study - the largest controlled clinical trial ever done in HIV-infected pediatric patients - was a landmark study demonstrating that combination therapy (AZT/3TC) was superior to monotherapy (didanosine) in terms of treatment-associated reduction in HIV-related disease progression and reduction in mortality. Importantly, the ACTG 300 study was done through an intensive collaborative effort of the NIAID's Division of AIDS and Glaxo Wellcome. This comprises a fine example of important, high quality research that can be done via such public/private collaborations.
Epivir products are now indicated for use in pediatric patients as young as three months of age. The labeling states that ''The safety and effectiveness of Epivir in combination with other antiretroviral agents have been established in pediatric patients three months of age and older.'' The results of ACTG 300 are featured in the labeling. Two key findings are reported. First, the overall frequency of HIV disease progression or death is less with Epivir/Retrovir (6.4%) than didanosine (15.7%). Second, the frequency of death is less with Epivir/Retrovir (0.8%) than didanosine (4.7%).
Epivir continues to be a key component of HIV research initiatives at Glaxo Wellcome, at other pharmaceutical companies, and at independent institutions around the world.
In adults and adolescents (12-16 years of age) with HIV infection, Epivir is dosed as one 150 mg tablet, twice daily, administered in combination with other antiretroviral drugs. The recommended oral dose of Epivir for pediatric patients 3 months to 12 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day) administered in combination with other antiretroviral agents.
In clinical trials in HIV, Epivir was generally well tolerated, with the most commonly reported side effects including headache, nausea, malaise and fatigue, nasal congestion and runny nose, and diarrhea. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Epivir and other antiretrovirals. Pancreatitis, which can be fatal, has occurred in pediatric patients with a history of prior antiretroviral therapy.
Under agreement, BioChem Pharma will receive royalties from Glaxo Wellcome on sales of lamivudine for use in both HIV/AIDS (3TC/Epivir/Combivir) and HBV (Zeffix/Epivir-HBV). Glaxo Wellcome has the right to develop, manufacture and sell lamivudine worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. The Company lists its common shares on the Montreal and Toronto exchanges (BCH) and on the NASDAQ National Market (BCHE).
BioChem Pharma news releases and other company information can be found on the World Wide Web at biochempharma.com.
Epivir, 3TC, Combivir, Zeffix, Epivir-HBV, Retrovir and Ziagen are trademarks of the Glaxo Wellcome Group of Companies.
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