Prolia, INN-denosumab

The legal basis for this application refers to Article 8.3 of Directive 2001/83/EC, as amended-complete and independent application The application submitted is a complete dossier composed of administrative information, complete quality data, non-clinical and clinical data based on applicants' own tests and studies and/or bibliographic literature substituting/supporting certain tests or studies. The applicant applied for the following indication: The treatment of osteoporosis in postmenopausal women at increased risk of fractures. Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. The treatment of bone loss associated with hormone ablation in men with prostate cancer and in women with breast cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures Information on Paediatric requirements Pursuant to Article 7, the application included an EMEA Decision P/89/2008 for the denosumab on the granting of a product-specific waiver in indication of bone loss associated with sex hormone ablative therapy. • Treatment of menopausal and other perimenopausal disorders.. on the granting of a class waiver. Scientific Advice The applicant did not seek scientific advice at the CHMP for these conditions. The product was not licensed in any country at the time of submission of the application. A new application was filed in the following countries: USA, Canada. • During the meeting of 15 – 18 March 2010 the CHMP concluded that overall balance of benefit-risk remains positive. In the light of the information submitted and the proposed revisions of the Summary of Product Characteristics, Package Leaflet and Risk Management Plan the CHMP adopted a revised opinion for granting a Marketing Authorisation for Prolia on 18 March 2010. The applicant provided the letter of undertaking on follow-up measures to be fulfilled post-authorisation on 17 March 2010. Osteoporosis is a systemic skeletal disorder characterised by low bone mass and micro-architectural deterioration of bone tissue, with consequent increase in bone fragility and susceptibility to fractures. Age and menopause are the two main determinants of osteoporosis. There are also other risk factors for osteoporotic fractures such as race, being underweight, hormone ablation therapy, dietary calcium deficiency, sedentary lifestyle, alcohol use, family history, and cigarette smoking. Compression fractures of the vertebrae and traumatic fractures of the wrist and femoral neck are the most common osteoporotic fractures, which cause a substantial clinical and economic burden for society. The aim of the pharmacological intervention is to decrease the …