CHMP Issues Positive Opinion for Latuda

The European Medicines Agency’s Committee for Medicinal Products for Human Use gave Takeda’s Latuda a thumbs up, recommending it for use in adults with schizophrenia age 18 years and older.

If the agency follows up quickly with marketing authorization, the drug could be available in individual EU member states starting in the second quarter of this year, Takeda spokeswoman Elissa Johnsen said.

In clinical trials, Latuda (lurasidone) was effective in treating positive and negative symptoms in acutely psychotic schizophrenia patients over six weeks and caused low rates of weight gain and lipid and glucose disturbance, Takeda said.

CHMP “considers there to be a favorable risk-to-benefit balance for Latuda and therefore recommends the granting of marketing authorization,” a summary of the opinion states. A pharmacovigilance plan will be implemented as part of the authorization, the committee said.

The recommendation is for once-daily Latuda in 18.5 mg, 37 mg and 74 mg doses.

Latuda is currently available in the U.S., Canada and Switzerland, and regulatory submissions are pending in Australia and Taiwan. Takeda is also conducting a Phase III trial of Latuda in Japan. — Lena Freund

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