Navigation Links
FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women

SILVER SPRING, Md., June 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

(Logo: )

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

"Due to its prevalence, osteoporosis is a serious concern to public health," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures."

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

For more information

Fast Facts on Osteoporosis – National Institute of Arthritis and Musculoskeletal and Skin Diseases

Media Inquiries: Elaine Gansz Bobo, 301.796.7567,

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 New Treatment for Late-Onset Pompe Disease
2. FDA Approves Cefepime for Use In B. Brauns DUPLEX(R) System
3. U.S. FDA Approves Natazia(TM), a New Oral Contraceptive for the Prevention of Pregnancy
4. FDA Approves New Combination Product Oral Contraceptive
5. FDA Approves Labeling Change for Vyvanse(R) (lisdexamfetamine dimesylate) Capsules CII to Include Supplemental Data Demonstrating Significant Efficacy at Two Hours Through 14 Hours After Administration in Adults with ADHD
6. FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer
7. FDA Approves New Device for Adults with Severe and Persistent Asthma
8. FDA Approves Drug to Treat Condition That Causes Elevated Ammonia Levels
9. FDA Approves First of Its Kind, Fully Implantable (Surgically), Invisible, Prosthetic Hearing Restoration Device
10. FDA Approves First Totally Implanted Hearing System
11. FDA Approves Watsons TRELSTAR(R) 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
Post Your Comments:
(Date:10/12/2015)... Given the intricacy of the anatomy and physiology of ... drug effectively to a specific ocular site. Several barriers have ... include dilution of a drug by tears, clearance of a ... issues with respect to the cornea, sclera and choroid. Approximately ... due to the aforementioned barriers. --> Given ...
(Date:10/12/2015)... 12, 2015  Former White House Spokesman, and Drug Czar ... House Narcotics Committee, Robert Weiner , and Policy Analyst ... two emphasize that this is now a potential bipartisan campaign ... Jeb Bush , Carly Fiorina to Rand ... federal statistics, which they call "a shocker: 23 million need ...
(Date:10/12/2015)... 2015  Luminex Corporation (NASDAQ: LMNX ) today announced ... ended September 30, 2015 on Monday, November 2, 2015. A ... the close of trading. --> ... discuss the operating highlights and financial results for the third ... 4:30 p.m. Eastern time. . Simply ...
Breaking Medicine Technology:
(Date:10/13/2015)... CA (PRWEB) , ... October 13, 2015 , ... According ... Care, a recent study has shown that women who successfully lose weight with a ... in the United States each year. The article notes that anywhere from 40 to ...
(Date:10/13/2015)... ... 13, 2015 , ... Altec Products, Inc., the leader in ... Dynamics AXUG, GPUG and NAVUG Summits to take place the week of October ... user conferences designed and led by users to provide attendees with a unique ...
(Date:10/13/2015)... ... 13, 2015 , ... Element Blue ™, a leading ... company, RightSensor™ LLC, an Internet of Things (IoT) hardware supplier that delivers custom ... approach for customers requiring sensor hardware for critical data environments. , RightSensor™, working ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... private messaging application, announced today a significant contract that will provide its award-winning ... plans to build on the growing success of its Relay program, IBX Wire™, ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... e-con Systems ... solutions, today announced See3CAM_CU40, the industry’s first RGB-IR pixel format camera with ... a new member of e-con’s See3CAM family of UVC USB 3.0 cameras, is based ...
Breaking Medicine News(10 mins):