HIV drug now available as oral powder for children
January 29th, 2012 - 9:20 pm ICT by IANS ( Leave a comment )New Delhi, Jan 29 (IANS) The HIV drug Viread will now be available in powder form for HIV positive children after its approval by the US Food and Drug Administration (FDA), a bio-pharmaceutical company said Sunday. The move is expected to benefit millions of HIV positive children.
“There remains an unmet need for heat-stable, taste-neutral pediatric formulations that do not require cold storage, particularly in resource-limited settings, where mother-to-child transmission remains a significant challenge,” Norbert Bischofberger, executive vice president, research and development and chief scientific officer at Gilead Sciences, said in a statement.
“We are very pleased to provide an important new therapeutic option for younger HIV patients, and will work to make the pediatric formulations of Viread available as quickly as possible,” Bischofberger added.
The FDA also approved a New Drug Application (NDA) for an oral powder formulation of Viread for children ages 2-5. The active ingredient in Viread, tenofovir disoproxil fumarate, is currently the most-prescribed molecule for adults receiving HIV therapy in the United States.
In pediatric patients, the use of either the lower-strength tablets or the oral powder formulation of Viread is based on the patient’s age and weight. The safety and efficacy of Viread has not been established in children less than two years of age. For adults unable to swallow Viread tablets, the oral powder formulation equal to 300 mg may be used.
According to the World Health Organization (WHO), there are approximately 2.5 million children under the age of 15 living with HIV worldwide, and more than 90 percent live in sub-Saharan Africa.
- Gilead's model to enhance availability of anti-AIDS drug - Feb 22, 2009
- AIDS Breakthrough Discovered For Women - Jul 20, 2010
- A Vaginal Gel Represents A Breakthrough In The War Against AIDS - Jul 20, 2010
- Latest Aids Pill Undergoing Trial Could Be The Next Medical Revolution - Apr 06, 2010
- US approves new HIV treatment - May 21, 2011
- New HIV/AIDS study could turn treatment 'on its head' - Mar 04, 2011
- FDA Says Hyland Teething Tablets May Harm Children - Oct 26, 2010
- Vaginal gel 'can cut HIV risk by 39pct in women' - Jul 20, 2010
- Work on inequalities to get rid of AIDS: UN - Dec 01, 2010
- Female-to-male HIV transmission risk doubles during pregnancy: Study - May 24, 2010
- Ranbaxy approved to make first generic version of Lipitor - Dec 01, 2011
- Anti-HIV vaginal gel deemed safe for rectal use too - Mar 01, 2011
- Gene change linked to increased risk of mother-to-child HIV transmission - May 25, 2010
- FDA-approved drugs that may fight HIV identified - Aug 21, 2010
- 2 tests better than 1 for diagnosing diabetes in overweight children - May 03, 2011
Tags: child transmission, cold storage, food and drug administration, food and drug administration fda, fumarate, gilead sciences, hiv drug, hiv patients, hiv therapy, living with hiv, norbert bischofberger, pediatric patients, powder formulation, sub saharan africa, tenofovir, therapeutic option, us food and drug administration, vice president research, viread, world health organization