Nycomed acquired the rights to develop and market the drug in Europe from NPS Pharmaceuticals in 2004. NPS Pharmaceuticals has filed a similar new drug application for clearance to market the drug under the brand name Preos in the US with the FDA.
The committee’s recommendation is the last step prior to receipt of marketing authorization by the European Medicines Agency (EMEA). If approval is eventually granted, Nycomed expects to be ready to launch Preotact in Europe during the second half of 2006. EU marketing authorization is valid in all 25 member states of the European Union.
“With 20 million women in Europe suffering from osteoporosis, Preotact represents an important new therapeutic option for these patients,” said Dr Hunter Jackson, NPS chairman and CEO.