FDA Approves Administration of LEXIVA(R) with Lower Dose of 'Boosting' Medication...( Data Show Lower Dose Associated w...)

Data Show Lower Dose Associated with Fewer Adverse Events in Healthy

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RESEARCH TRIANGLE PARK, N.C., Oct. 12 /PRNewswire-FirstCall/ -- GlaxoSmithKline's (NYSE: GSK) HIV protease inhibitor LEXIVA(R) (fosamprenavir calcium) may now be administered with 100mg of ritonavir, an agent that increases, or boosts, the level of protease inhibitors in the bloodstream.

The U.S. Food and Drug Administration approved once-daily LEXIVA 1400 mg with 100mg of ritonavir in adult patients who had not previously taken a protease inhibitor (PI). The approval was based on pharmacokinetic data demonstrating comparable blood plasma levels in healthy volunteers when LEXIVA was administered with the lower 100mg dose of ritonavir and the previously approved 200mg dose of ritonavir. This information has been added to the LEXIVA product label.

LEXIVA is indicated in combination with other antiretrovirals for the treatment of HIV infections. Ritonavir works with LEXIVA and other protease inhibitors to boost the medication level in the bloodstream making the protease inhibitor more effective in suppressing HIV. HIV medicines do not cure HIV infections/AIDS or prevent passing HIV to others.

"GlaxoSmithKline remains committed to improving patient care by making dosing options more convenient," said Mark Shaefer, Pharm. D., Director, Clinical Development at GlaxoSmithKline. "We understand that reducing the number of pills taken daily is an important consideration for patients starting HIV treatment."

The data supporting this label change were published in the February 2007 issue of Antimicrobial Agents and Chemotherapy.

LEXIVA Indication Statement and Background

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