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Prostate drug application withdrawn


The European Medicines Agency (EMEA) has received formal notification that marketing approval for quantities of a drug which had been expected to combat prostate cancer will not be sought.

Pharmion Ltd has decided to withdraw its application for centralised marketing approval for the medicine Orplatna (satraplatin) in 10 mg and 50 mg capsules.

Orplatna was expected to be used, in combination with prednisone and prednisolone, to treat patients with metastatic hormone-refractory prostate cancer who have not responded to earlier chemotherapy.

The application for marketing authorisation was submitted in June last year. At the time of the withdrawal, the drug was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

In an official letter, the company said the withdrawal of Orplatna was due to the CHMP’s view that the data provided do not allow the Committee to conclude a positive benefit-risk balance for Orplatna for the applied indication.

Copyright PA Business 2008

Pharmion Ltd

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