The European Commission (EC) has granted marketing authorisation for Japanese pharmaceutical firm Dainippon Sumitomo Pharma’s (DSP’s) once-daily oral Latuda (lurasidone) for treatment of schizophrenia in adults.
Approval was based on a comprehensive clinical trial programme of eight positive studies, which included placebo and active comparators.
The review also included more than 50 clinical trials and over 4,500 lurasidone-treated subjects.
In these trials, lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia.
Lurasidone also showed a statistically significant separation from placebo seen as early as day four on primary efficacy measures in some major trials in schizophrenia.
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By GlobalDataMost frequent adverse reactions seen in short-term clinical studies were somnolence, akathisia, nausea, parkinsonism and dystonia.
The trials have shown that lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia.
It also showed significant reductions in mean weight and BMI over 12 months in contrast to increases in risperidone-treated patients.
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) had earlier issued a positive opinion for Latuda in January 2014.
Uni-Psychiatrie München director Hans-Jürgen Möller said that many people living with schizophrenia struggle to remain on treatment due in part to the side-effects associated with currently available therapies.
“Today’s announcement means that physicians within the European Union will have access to a new treatment to help eligible patients manage their disease,” Möller said.
“Flexible treatments that are convenient for patients and that can help to control the numerous and complex factors associated with schizophrenia, may be of value to patients, as well as their families and caregivers.”
Developed by DSP, Latuda is an atypical antipsychotic agent with an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects.
DSP president and chief executive officer Masayo Tada said lurasidone is the company’s core product for global expansion.
“We intend to build upon the success lurasidone has shown in the United States and through the partnership with Takeda to ensure we provide this new treatment option to patients across Europe,” Tada said.
Sunovion Pharmaceuticals Europe, a subsidiary of DSP, will be responsible for marketing latuda in the UK, while marketing of the drug across Europe will be done by Takeda subsidiaries.
Lurasidone was previously launched as Latuda for treatment of schizophrenia in adults in the US in February 2011, followed by Canadian launch in September 2012 through DSP’s subsidiary Sunovion Pharmaceuticals and later in Switzerland in September 2013 by Takeda.
A Phase III clinical study is currently underway for treating schizophrenia by DSP in Japan.
In addition, DSP intends to launch the product in Australia, Taiwan, China and South East Asia.
