Navigation Links
FDA Expands Use of HIV Drug Isentress to Children and Adolescents
Date:12/21/2011

SILVER SPRING, MD., Dec. 21, 2011 /PRNewswire-USNewswire/ -- Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The drug is part of a class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. It was first approved for use in adult patients in October 2007, under FDA's accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.

The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug's clinical benefit.

"Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment," said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

Isentress is a pill that can be taken twice daily, with or without food. The pill is also available in a chewable form. Because the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.

A single, multi-center clinical trial of 96 children and adolescents ages 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.

The most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping (insomnia) and headache. The frequency of these side effects is similar for children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash. The drug should be discontinued if this occurs.

Isentress does not cure HIV infection. Patients must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

Isentress is made by Whitehouse Station, N.J.-based Merck & Co., Inc.

For more information:

FDA: HIV and AIDS Activities
http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/HIVandAIDSActivities/default.htm

FDA: Antiretroviral drugs used in the treatment of HIV infection
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm

CDC: HIV/AIDS
http://www.cdc.gov/hiv/default.htm

HHS: AIDS News and Resources
http://www.aids.gov/

AIDS Information
http://www.aidsinfo.nih.gov/

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Radient Pharmaceuticals Corporation Expands Distribution of Onko-Sure® in Asia; Receives Payment on First Order of 60 Kits
2. Saladax Biomedical, Inc. Expands Distribution of My5-FU in Europe
3. Lilly for Better Health™ Expands Website to Include Spanish Health Information and Interactive Tools
4. Sony Expands Radiology Product Offerings with Full Line of Diagnostic Displays
5. Leading Indian CRO Max Neeman International Expands in Response to Positive Biosimilars Market in India
6. Panasonic Expands on Hearing Instrument Lineup
7. Gaylord Sleep Medicine Expands Sleep Apnea Management Program
8. Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for an Additional Investigational Cancer Immunotherapy Antigen
9. Free Statewide Rx Assistance Program Expands
10. AQUA® Technology Expands to Additional Digital Pathology Platform with Launch of Vectra™ 2 from Caliper Life Sciences, a Perkin-Elmer Company
11. Cincinnati Based Laboratory Furniture Regional Dealer and Representative Expands to Michigan
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... 24, 2017 Research and Markets has announced the ... Industry Forecast to 2025" report to their offering. ... The Global Empty Capsules Market is poised ... to reach approximately $2.9 billion by 2025. This industry ... on global as well as regional levels presented in the research scope. ...
(Date:2/24/2017)... HARRISBURG, Pa. , Feb. 24, 2017 ... Secretary of Drug and Alcohol Programs Jennifer Smith ... role in providing training for and using naloxone, a ... Mark McCullough , a recovery specialist and overdose ... naloxone by EMS providers. "A significant part ...
(Date:2/24/2017)... Juan Monteverde , founder and managing ... boutique securities firm headquartered at the Empire State Building ... that a class action lawsuit has been filed in the ... Inotek Pharmaceuticals Corporation (NASDAQ:  ITEK)("Inotek" or the "Company") on ... 2015 and December 30, 2016, inclusive (the "Class Period").  ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... February 24, 2017 , ... Congratulations to ... Elite division on February 12th. Ms. Esparza qualified into this prestigious status ... competition held in Las Vegas, Nevada. Frida is one of approximately 25 gymnasts ...
(Date:2/23/2017)... ... February 23, 2017 , ... Thinksport, the most award-winning ... Gran Fondo of Marin. For the second year in a row, cyclists will ... , “We are thrilled to provide our safe, non-toxic sunscreen to over 2,000 ...
(Date:2/23/2017)... ... ... The 89th Academy Awards will be celebrated this weekend, which means it’s ... Award. We invite you to enjoy our 11th annual tongue-in-cheek “salute” to the shoddiest ... for American Progress (CAP), for its report, Lessons From State Performance on NAEP: Why ...
(Date:2/23/2017)... ... February 23, 2017 , ... ... a clinician-based audience, will be participating in Rare Disease Day events, hosted by ... In addition, Rare Disease Report, a website, weekly e-newsletter and quarterly publication, will ...
(Date:2/23/2017)... ... , ... Los Angeles-based weight loss surgeon Michael Feiz, M.D., F.AC.S. will be ... Hot,” which will begin airing on February 24, 2017. The show chronicles the weight ... reality television series, “Here Comes Honey Boo Boo.” The earlier series from TLC lasted ...
Breaking Medicine News(10 mins):