FDA agrees to review Vanda Pharmaceuticals’ sNDA for Fanapt

The company is seeking approval depending on the Reprieve clinical study results, which determined the long-term maintenance of efficacy and safety of Fanapt antipsychotic agent.

The agency is planning to complete its review by 27 May 2016.

Vanda said in selecting among treatments, prescribers need to initially consider the ability of Fanapt for prolonging the QT interval and the use of other drugs.

They are also urged to consider the need to titrate Fanapt slowly in order to prevent orthostatic hypotension, which could result in delayed effectiveness compared to other drugs that do not require similar titration.

Novartis has development and commercial rights to Fanapt in the US and Canada. FDA granted US market approval for Fanapt in May 2009.

Vanda currently has Fanapt distribution partnerships in Israel and Mexico. The company has approvals to market the product in Israel and Argentina.

The company said Fanapt belongs to a class of medications for schizophrenia known as atypical antipsychotics.

Under two placebo- and active-controlled short-term trials, the company derived safety data from over 2,000 patients in short- and long-term studies.

The company enrolled patients who met the DSM-III/IV criteria for schizophrenia. Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia using the positive and negative symptom scale and the brief psychiatric rating scale.