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Amgen And UCB Submit Biologics License Application For Romosozumab To The FDA
"Osteoporosis is a large public health problem yet is often overlooked, even in patients who have already experienced an osteoporotic fracture,"1,2 said
The BLA for romosozumab is based on data from the pivotal Phase 3 placebo-controlled FRActure study in postemenopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients.
"Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs.1,3,4 Many patients often view fragility fractures as part of aging,5 but these fractures are an indication of a weakened skeleton and a signal for intervention with medication," said Dr.
Osteoporosis-related fragility fractures are common.1,6 In
Romosozumab is an investigational bone-forming agent and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis.
About the FRAME study
FRAME is a multi-center, international, randomized, double-blind, placebo-controlled, parallel-group study in postmenopausal women with osteoporosis, defined as low bone mineral density at the total hip or femoral neck. The study evaluated the effectiveness of romosozumab treatment, compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also further evaluated if romosozumab treatment for 12 months followed by denosumab treatment for 12 months, compared with placebo followed by denosumab treatment, was effective in reducing the risk of new vertebral fractures through 24 months. In addition, clinical fracture (a composite endpoint of non-vertebral and symptomatic vertebral fractures) risk reduction, non-vertebral fracture (fractures outside of the spine, excluding sites that are not considered osteoporotic, fractures due to high trauma or pathologic fractures) risk reduction and other endpoints were assessed at 12 and 24 months. The most common adverse reactions (greater than or equal to 10 percent) reported in the Phase 3 FRAME study were arthralgia and nasopharyngitis.
7,180 patients were randomized 1:1 to receive either 210 mg romosozumab subcutaneous (SC) monthly (QM) or placebo SC QM for the 12-month double-blind study period. After the placebo-controlled study period, patients entered the open-label phase where all patients received 60 mg denosumab SC every six months (Q6M) for 12 months, while remaining blinded to initial treatment. An additional 12 month extension period of open-label 60 mg denosumab SC Q6M is currently ongoing.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.
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Isabelle Ghellynck, Investor Relations, UCB
1 Reginster JY, Burlet N. Osteoporosis: A still increasing prevalence. Bone. 2006 Feb;38 (2 Suppl 1):S4-9.
2 Wilk A et al. Post-fracture pharmacotherapy for women with osteoporotic fracture: analysis of a managed care population in the
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