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LEXIVA Liquid Approved for Treatment of HIV in Pediatric Patients
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Announcement from GSK
Research Triangle Park, NC - June 18, 2007 - The U.S. Food and Drug Administration (FDA) has approved a liquid formulation of the protease inhibitor LEXIVA (fosamprenavir calcium) for use in patients aged 2 to 18 infected with HIV.
The new oral suspension, used in combination with other HIV antiretroviral therapies, provides a therapeutic alternative for the treatment of children with HIV, a patient population with comparatively fewer treatment options than adults. GlaxoSmithKline currently manufactures five of the twelve medications approved for the management of HIV disease in patients under 18.
"Many advances have been made in HIV treatment for pediatric patients, but children do not have the same treatment options as adults, necessitating the development of new antiretroviral therapies with pediatric indications and formulations," said Judith Millard, Ph. D., Director, HIV, Infectious Disease Medicine Development Center at GlaxoSmithKline. "The development and approval of the pediatric formulation for LEXIVA underscore GSK's commitment to improving pediatric HIV care."
The safety, pharmacokinetic profile and anti-viral activity of LEXIVA Oral Suspension and Tablets were evaluated in pediatric patients aged 2 to 18 years. Eighteen protease-inhibitor naive pediatric patients received LEXIVA Oral Suspension twice daily without ritonavir in combination with two other HIV medicines. At week 24, 67 percent of these patients (12/18) achieved HIV RNA <400 copies/mL, and the median increase from baseline in CD4 +cell count was 353 cells/mm3. Of the patients receiving LEXIVA Oral Suspension or Tablets with ritonavir twice daily in combination with two other HIV medicines, 27 were protease-inhibitor naive and 30 were protease-inhibitor experienced. At week 24, 70 percent of the protease-inhibitor naive patients (19/27) and 57 percent of the protease-inhibitor experienced patients (17/30) achieved HIV RNA <400 copies/mL; median increases from baseline in CD4+ cell counts were 131 cells/mm3 and 149 cells/mm3 in protease inhibitor-naive and experienced patients, respectively.
The most common adverse reactions in adults associated with LEXIVA include diarrhea, rash, nausea, vomiting, and headache. The adverse reaction profile seen in pediatric patients taking LEXIVA is similar to that observed in adult patients with the exception of vomiting. Vomiting from any cause occurred more frequently among pediatric patients receiving LEXIVA twice daily, with and without ritonavir, compared with adults receiving LEXIVA twice daily.
Dose information
LEXIVA Oral Suspension will be available in a strength of 50 mg/mL.
Pediatric patients should take LEXIVA Oral Suspension twice daily with food. Adults should take the Oral Suspension without food. Therapy-na¥ve patients 2 to 5 years of age should take LEXIVA Oral Suspension without ritonavir. LEXIVA Oral Suspension may be taken with or without ritonavir by therapy-na¥ve patients 6-18 years of age. Therapy-experienced patients 6-18 years of age should take LEXIVA Oral Suspension with ritonavir. There are insufficient data to recommend dosing of LEXIVA in therapy-experienced patients 2 to 5 years of age. The recommended dosage of LEXIVA in patients 2 years and older should be calculated based on body weight (kg) and should not exceed the recommended adult dose.
LEXIVA indication and background
LEXIVA is indicated for the treatment of HIV infection in combination with other antiretroviral medications. The following points should be considered when initiating therapy with LEXIVA plus ritonavir (LEXIVA/r) in PI-experienced patients: the PI-experienced patient study was not large enough to reach a definitive conclusion that LEXIVA/r and lopinavir/ritonavir are clinically equivalent. Once-daily administration of LEXIVA plus ritonavir is not recommended for adult PI-experienced patients or any pediatric patients.
IMPORTANT SAFETY INFORMATION ABOUT LEXIVA
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.
Patients should not take LEXIVA if they have had an allergic reaction to LEXIVA or AGENERASE (amprenavir). High blood sugar, diabetes or worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors. When a patient starts taking HIV medicines, his immune system may get stronger and could begin to fight infections that have been hidden in his body, such as pneumonia, herpes virus, or tuberculosis. If a patient has new symptoms after starting his HIV medicines, he should tell his doctor. Changes in body fat may occur in some patients taking antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Skin rashes can occur in patients taking LEXIVA.
Rarely, rashes were severe or life threatening. Opportunistic infections can develop when a patient has HIV and his immune system is weak. It is very important that patients see their healthcare provider regularly while taking LEXIVA to discuss any side effects or concerns. Most common side effects in clinical studies were diarrhea, headache, nausea, rash, and vomiting. In most cases, these side effects did not cause people to stop taking their medicine.
For full prescribing information for LEXIVA, please visit www.treathiv.com
LEXIVA, marketed by GlaxoSmithKline, was first approved for use in combination with other antiretrovirals for the management of HIV in adults in 2003.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.
GSK's Bridges to Access program can help provide qualified individuals with access to GSK's antiretroviral medications, as well as help identify insurance or other support for medications. Patients may be eligible for this program if they are not eligible for prescription drug benefits through any other private or public insurer, payer or program. In 2004, GlaxoSmithKline donated more than $372.5 million worth of prescription drugs to 475,000 patients. For more information, visit www.bridgestoaccess.gsk.com or call 1-866-PATIENT.
LEXIVA was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals Incorporated. LEXIVA was approved by the FDA for use in the US in 2003.
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