Bone/Mineral Metabolism

Top Story

Amgen receives FDA response letter for romosozumab

July 17, 2017

Amgen has received a Complete Response Letter for the Biologics License Application from the FDA asking the company to add safety and efficacy data from the ARCH and BRIDGE studies into the drug application for romosozumab as a treatment for postmenopausal women with osteoporosis, according to a company press release.

The original application, submitted to the FDA in September 2016, was based on efficacy and safety data from the phase 3 placebo-controlled Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) conducted in nearly 7,200 women. Integrated into the application will be data from the ARCH study, which showed a 50% reduction in the relative risk for spinal fracture, a 19% reduced risk for nonvertebral fracture and a 72% reduced risk for clinical fracture in postmenopasaul women treated with romosozumab (EVENITY). A 2.5% incidence of cardiovascular events after 12 months was reported. Safety and efficacy data from the BRIDGE study, which evaluated romosozumab in men with osteoporosis, will also be included.

In the Journals Plus

Romosozumab therapy increases BMD in postmenopausal Japanese women with osteoporosis

July 14, 2017
Postmenopausal Japanese women with osteoporosis assigned the monoclonal antibody romosozumab experienced gains in bone mineral density at the lumbar spine, total hip and…
In the Journals Plus

Alendronate, prednisolone combination lowers fracture risk

July 11, 2017
Adults treated with prednisolone and alendronate had reduced risk for hip fracture, major osteoporotic fracture, any fracture and nonvertebral fracture compared with…
In the Journals Plus

Serum osteoprotegerin levels may predict fracture, CVD risk in older men

July 10, 2017
Older men with higher levels of serum osteoprotegerin are twice as likely to sustain a fracture or experience acute coronary syndrome or cardiac death vs. older men who…
CME

Improving Bone Strength and Reducing Fracture Risk in Osteoporosis

This activity is supported by an educational grant from Merck & Co., Inc.

Osteoporosis is characterized by low bone mass and microarchitectural deterioration of bone tissue leading to reduced…
More »
Video
Meeting News

VIDEO: Bone screens still necessary in type 2 diabetes despite normal, high BMD

April 3, 2017
More »
Resource Centers
Heart in Diabetes

Heart in Diabetes

CME

Practical Lipidology®: Volume 3, Number 2

This activity is supported by an educational grant from Amgen

The reduction of low-density lipoprotein-cholesterol (LDL-C) is recognized as the primary strategy for decreasing…
More »
Advertisement
Advertisement