Preotact gets EU Marketing approval

USA-based NPS Pharmaceuticals and Danish drugmaker Nycomed say that the European Commission has granted marketing authorization for Preotact (parathyroid hormone [rDNA origin] for injection). The drug, which is referred to as PREOS in the USA, recently received an "approvable letter" from the US Food and Drug Administration for consideration as an osteoporosis treatment (Marketletter March 20, 2006). The agency did express concerns regarding hypercalcemia associated with the proposed daily dose of the drug, and requested additional reliability data relating to the injection device used in its administration. NPS says it has requested a meeting with the FDA to address these issues.

The European Medicines Agency (EMEA) has approved Preotact for the treatment of postmenopausal women with osteoporosis at risk of fractures. NPS, which licenses the compound from the Roskilde-headquartered firm, said that approval is a significant event for both firms, adding that it looked forward to the European launch of the product later in the year. The marketing authorization is valid in all 25 member states of the European Union.