EMA approves generic zoledronic acid
Indicated for prevention of skeletal related events in patients with bone metastases from advanced malignancies and treatment of tumour-induced hypercalcemia
- Date : 07 Mar 2012
- Topic : Anticancer agents & Biologic therapy
On 16 February 2012 the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zoledronic acid Actavis 4mg/5ml concentrate for solution for infusion intended for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcemia) in adult patients with advanced malignancies involving bone, and the treatment of tumour-induced hypercalcemia. The applicant for this medicinal product is Actavis Group PTC ehf.
Generic of Zometa
The active substance of Zoledronic acid Actavis is zoledronic acid, (as monohydrate) a bisphosphonate (M05BA08). Zoledronic acid stops the action of the osteoclasts. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases. By preventing the breakdown of bones, zoledronic acid also helps to reduce the amount of calcium released into the blood.
Zoledronic acid Actavis is a generic of Zometa, which has been authorised in the EU since 20 March 2001. Studies have demonstrated the satisfactory quality of Zoledronic acid Actavis. This product is administered intravenously and is 100% bioavailable; therefore, a bioequivalence study versus the reference product Zometa was not required.
A pharmacovigilance plan for Zoledronic acid Actavis will be implemented as part of the marketing authorisation.
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcemia) in adult patients with advanced malignancies involving bone.
- The treatment of tumour-induced hypercalcemia.
Zoledronic acid Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous biphosphonates.
Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report, and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit to risk balance for Zoledronic acid Actavis and therefore recommends the granting of the marketing authorisation.
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