Navigation Links
FDA Approves New HIV Treatment
Date:5/20/2011

SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).

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

Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitor (NNRTI). The drug works by blocking HIV viral replication. Edurant is to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of HIV (viral load) in the blood. Edurant is a pill taken once a day with food.

"Patients may respond differently to various HIV drugs or experience varied side effects. FDA's approval of Edurant provides an additional treatment option for patients who are starting HIV therapy," said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of Edurant is based on 48-week data from two Phase 3 clinical trials with 1,368 adult subjects with HIV infection, and from a 96-week (with extension to 192 weeks) trial. Patients had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz (another FDA-approved NNRTI for the treatment of HIV infection). Both drugs were given in combination with other antiretroviral drugs.

Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83 percent and 80 percent of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than were patients with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz.

The most commonly reported side effects in patients taking Edurant included depression, difficulty sleeping (insomnia), headache and rash. Fewer patients stopped taking the drug due to side effects as compared to patients taking efavirenz.

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

Edurant is manufactured by Raritan, N.J.-based Tibotec Therapeutics, a division of Centocor Ortho Biotech 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. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/1/2017)... June 1, 2017 Nutriceutical Holdings (NH), parent ... Solutions (VRS), and KD Pharma Group have decided to ... by KD Pharma Group. KD Pharma Group will become ... to acquire the entire company. "We believe ... are committed to growing the NH companies by providing ...
(Date:5/26/2017)... 26, 2017  Endo International plc (NASDAQ: ENDP ... CEO, will represent the Company in a fireside chat at ... Tuesday, June 13, 2017 at 10:40 a.m. PT / 1:40 ... in Rancho Palos Verdes, CA. ... will be available on the Company,s website at http://www.endo.com/investors/overview ...
(Date:5/22/2017)...  As the specialty pharmacy industry and the ... the revolutionary shift from volume-based to value-based care, ... patient outcomes and shaping the future of the ... from clinical trials and toward data that reveals ... therapy utilization in precise patient populations. Therigy ® ...
Breaking Medicine Technology:
(Date:6/24/2017)... , ... June 24, 2017 , ... The weather is ... time outdoors. Home and business owners should be aware that the summer months provide ... In fact, mechanical locks and keys can be negatively affected from direct exposure to ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Rhode Island Quality ... Management Alerts and Dashboards, an innovative new service enabling healthcare providers to proactively ... Management Alerts and Dashboards provide near real-time data about patients admitted to and/or ...
(Date:6/23/2017)... , ... June 23, 2017 , ... By scoring 100% ... ninth consecutive four-star rating from premier online charity evaluator, Charity Navigator, validating ANRF's work ... 1% of all charities reviewed by Charity Navigator and earns ANRF a spot on ...
(Date:6/23/2017)... , ... June 24, 2017 , ... Studies show evidence ... reduce the risk of visual loss in these patients. , But how often do ... or smoking cessation to patients at risk of or with early symptoms of AMD? ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... plastic surgeon practicing in Newburgh, New York, has recently begun offering three new ... to offering the best cutting-edge procedures and reducing downtime, Dr. Rubinstein is excited ...
Breaking Medicine News(10 mins):