AOP Orphan files for new use for tetrabenazine in Europe

Austrian rare diseases specialist AOP Orphan Pharmaceuticals says it has filed a regulatory submission for tetrabenazine for the treatment of tardive dyskinesia in a decentralized procedure (DCP) for several European countries with UK being reference member state.

Tardive dyskinesia (TD) is a chronic movement disorder caused by prolonged exposure to medications that block dopamine receptors, including antipsychotic drugs and some drugs used to treat nausea. It is characterized by involuntary, repetitive movements that usually involve the face and in more severe cases affect the trunk and/or extremities. Involuntary movements of the lips, cheeks, tongue and jaw are typical. The disorder is irreversible in the majority of cases.

"The opportunity to bring relief to the many patients who face the debilitating effects of movement disorders and suffer from the effects of conditions such as tardive dyskinesia is greatly needed and humbling," said Rudolf Widmann, chief executive and founder of AOP Orphan.