AOP Orphan gains EU OK for Thromboreductin

Austria's AOP Orphan Pharmaceuticals says that it has achieved itsintermediate goal to make Thromboreductin (anagrelide) available in the European Union by means of an ambitious Good Manufacturing Practices-compliant clinical trial program. Thromboreductin is the first anagrelide-containing medicinal product approved within the EU and is thus available for the treatment of patients with essential thrombocythemia, a rare myeloproliferative disorder which can cause life-threatening complications.

Until recently, hydroxyurea was the only drug approved for treatment of ET in some EU countries. However, this has a potential risk of inducing leukemia during lon- term treatment, whereas Thromboreductin is devoid of any leukemogenic risk, according to AOP Orphan.

The granting of the marketing authorization strongly supports AOP Orphan's concept of maintaining the Good Clinical Practice standard in the development of orphan drugs, as requested by EU regulatory authorities, the company notes. In the case of Thromboreductin, this means that the developmental work will be finalized by completion of the currently-ongoing AOP Orphan Phase III ANAHYDRET study, it says.