The European Medicines Agency (EMEA) has accepted for review Pharmion Corporation (Nasdaq: PHRM)’s Marketing Authorization Application (MAA) (submitted in January 2007) for Thalidomide Pharmion (thalidomide) for the treatment of untreated multiple myeloma – the second most common cancer of the blood.
According to Patrick J. Mahaffy, President and CEO of Pharmion:
"We believe that these data clearly demonstrate the value Thalidomide Pharmion provides patients with untreated multiple myeloma. Based on these strong results, we believe that it is time that this widely used and critical therapy come under regulatory oversight to ensure equal and regulated access to its benefits throughout Europe."
Already approved in Australia, New Zealand, Turkey, Israel, South Korea and Thailand for the treatment of multiple myeloma after the failure of standard therapies, Thalidomide Pharmion has been designated an Orphan Medicinal Product status in the EU for the treatment of multiple myeloma – which when approved, entitles the drug to ten years of market exclusivity for the approved indications.
In the United States, Thalomid® (thalidomide) was approved in May 2006 by the USFDA Administration (FDA) in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma.
Find more details from the press release.
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