Vanda Pharmaceuticals Inc. (Vanda), a biopharmaceutical company, announced that its marketing authorisation application (MAA) for oral Fanaptum tablets has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults.
"The MAA validation demonstrates Vanda's commitment to offer another option to the healthcare community to treat a severe, disabling mental disorder," said Mihael H. Polymeropoulos, M.D., Vanda's president and CEO. "This continues our efforts to expand the availability of iloperidone to people who we believe would benefit from this treatment option."
The MAA is primarily supported by data from two placebo- and active-controlled clinical trials and one long term randomized clinical trial. Fanaptum was shown to be superior to placebo in controlling symptoms of schizophrenia.
Iloperidone is currently approved in the US as Fanapt for the treatment of schizophrenia in adults. Fanapt is also approved and marketed in Israel and Mexico.
Fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
Commonly observed adverse reactions of Fanapt (>=5 per cent and 2x placebo) include dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.