CHMP Says No to Antipsychotic for Acute Schizophrenia

Megan Brooks

July 21, 2017

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended against approval of the antipsychotic iloperidone (Fanaptum, Vanda Pharmaceuticals Ltd) as a treatment for acute schizophrenia in adults.

In seeking approval, the company presented results of two main studies of 4 and 26 weeks’ duration.

The short-term study, involving 567 patients, compared iloperidone with ziprasidone (Geodon, Pfizer) and with placebo. The long-term study, which involved 193 patients, compared iloperidone with placebo.

The CHMP felt the effectiveness of iloperidone was "modest" and also noted that the drug's effects start only after 2 to 3 weeks of treatment, "which is a concern" when treating acute episodes of schizophrenia, the committee said in a news release.

The CHMP was also concerned about iloperidone's cardiac effects, noting that the antipsychotic causes QT prolongation, which can cause a life-threatening abnormality of heart rhythm. The committee said that this risk was "significant despite the measures proposed by the company to minimize it."

The CHMP was also concerned that iloperidone is metabolized by liver enzymes for which activity is reduced in certain patients and by certain other medicines. As a result, blood concentrations of the drug may be increased in some patients, which would increase their risk for QT prolongation.

On the basis of these concerns, the CHMP concluded that the benefits of iloperidone do not outweigh its risks and recommended against marketing authorization.

The company has the option of asking the committee to take a second look within 15 days of receipt of notification of this negative opinion.


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