• GOOD NEWS FOR ROMOSOZUMAB

    An FDA advisory panel on Wednesday voted 18-1 that the benefits of Amgen and UCB's monthly injection Evenity (romosozumab) outweigh its risks for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Two members of the panel voted in favour of the sclerostin inhibitor, but proposed approving it for a different indication. The committee also raised concerns of potential cardiovascular risks linked to Evenity, which FDA staff reviewers earlier this week had cited as the main reason for convening the advisory panel meeting.  In 2017, the agency issued a complete response letter to the companies regarding their submission of Evenity, asking them to include efficacy and safety data from the Phase III ARCH study in their filing. In the trial, Evenity was associated with a higher rate of serious cardiovascular adverse events than Merck & Co.'s Fosamax (alendronate). Amgen and UCB resubmitted their filing seeking approval of Evenity to the FDA last July. Still, despite the panel vote backing approval, some panellists again expressed concerns about the drug's cardiovascular risks. "I don't think we've adequately characterised cardiovascular safety," said Pamela Shaw, who voted in favour of approval for Evenity. She added "I don't know the perfect solution, but relying on observational data only post approval, I don't think, will help us answer this reliably. My vote is relying on a high-quality post-marketing study."  Evenity was approved earlier this month for the treatment of osteoporosis in patients at high risk of fracture in Japan, where the therapy is jointly marketed by Astellas.

     

    George Τrovas

    Endocrinologist
    Laboratory for Research of the Musculoskeletal System (LRMS)
    National and Kapodistrian University of Athens

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Guidelines for the diagnosis and treatment of Osteoporosis in Greece 2017

Guidelines for the diagnosis and treatment of Osteoporosis in Greece 2017

Available only in Greek

Guidelines for the proper use of Calcium and Vitamin D supplements

Guidelines for the proper use of Calcium and Vitamin D supplements

Available only in Greek

Φυσικοθεραπευτική διαγνωστική προσέγγιση και αποκατάσταση υπερηλίκων ασθενών με σύνδρομο ευπάθειας

Φυσικοθεραπευτική διαγνωστική προσέγγιση και αποκατάσταση υπερηλίκων ασθενών με σύνδρομο ευπάθειας

Age-related changes in cortical bone

Age-related changes in cortical bone

Available only in Greek

Oxidative Stress and Metabolic Bone Diseases

Oxidative Stress and Metabolic Bone Diseases

Available only in Greek

The role of osteocyte in immobilization-induced bone loss

The role of osteocyte in immobilization-induced bone loss

Available only in Greek

Diffuse Idiopathic Skeletal Hyperostosis

Diffuse Idiopathic Skeletal Hyperostosis

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Medical terms & definitions on metabolic bone diseases

Medical terms & definitions on metabolic bone diseases

Available only in Greek

Fracture risk prediction in osteoporotic patients

Fracture risk prediction in osteoporotic patients

Available only in Greek

A Guide to the Design and Execution of Clinical Trials

A Guide to the Design and Execution of Clinical Trials

Available only in Greek

Magnesium Metabolism and its Disorders

Magnesium Metabolism and its Disorders

Available only in Greek

Animal Models of Osteoporosis

Ανδρική Οστεοπόρωση

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Mechanisms of Autoimmunity in Osteoclastogenesis

Mechanisms of Autoimmunity in Osteoclastogenesis

Available only in Greek

Nutrition and Skeletal Health

Nutrition and Skeletal Health

Available only in Greek

Exercise for Osteoporosis and Falls Prevention

Exercise for Osteoporosis and Falls Prevention

Available only in Greek