OSAKA, Japan I March 31, 2014 I Dainippon Sumitomo Pharma Co., Ltd. (“DSP”) (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited (“Takeda”) (Head Office: Osaka, Japan) today jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda® (lurasidone) for the treatment of schizophrenia in adults. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for Latuda on January 23, 2014.
About 3.5 million people in Europe are currently living with schizophrenia which can have a huge impact on those affected, their families and caregivers.1 Symptoms can be diverse and include hallucinations, distorted reality, depression and social withdrawal. Schizophrenia is also associated with shortened life expectancy of 10-22.5 years,2,3 which can in part be due to the undesirable effects of antipsychotics such as weight gain, increased blood pressure and increased blood sugar.4,5 The leading cause of mortality for people with schizophrenia is cardiovascular disease5 – an estimated 75% die from this versus a general population mortality rate of 50%.6
Prof. Hans-Jürgen Möller, Direktor der Uni-Psychiatrie München said, “We know 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. 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.”
The Marketing Authorization was based on a comprehensive clinical trial program of eight positive studies, which included placebo and active comparators. The review also contained more than 50 clinical trials and more than 4,500 lurasidone-treated subjects. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia.7,8,9,10,11 In short and long term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change.9,10,12 It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.5
Lurasidone demonstrated a statistically significant separation from placebo seen as early as day four on primary efficacy measures in some of the pivotal trials in schizophrenia.7 The most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, parkinsonism and dystonia.13
Clinical studies 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.14,15,16,17
Lurasidone demonstrated significant reductions in mean weight and BMI over 12 months in contrast to increases in risperidone-treated patients.12 In separate studies, lurasidone demonstrated significant reduction in clinically significant weight gain (≥ 7%) compared to quetiapine XR over 12 months18, and patients switching from olanzapine to lurasidone experienced mean weight loss during the subsequent 6 months.19
“Lurasidone is the DSP Group’s core product for global expansion, and I am very pleased that we have achieved the important milestone of the approval of lurasidone for schizophrenia in Europe,” said Masayo Tada, President and Chief Executive Officer of DSP. “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.”
“We are very pleased with the marketing authorization of lurasidone in the European Union,” said Yasuchika Hasegawa, president & CEO of Takeda. “We believe lurasidone represents an important new treatment option for people in Europe living with schizophrenia. This milestone also enhances our central nervous system franchise, one of our core therapeutic areas.”
Latuda will be marketed in the UK by Sunovion Pharmaceuticals Europe Ltd., a subsidiary of DSP, and across Europe by Takeda subsidiaries.
SOURCE: Takeda Pharmaceutical Co
Post Views: 81
OSAKA, Japan I March 31, 2014 I Dainippon Sumitomo Pharma Co., Ltd. (“DSP”) (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited (“Takeda”) (Head Office: Osaka, Japan) today jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda® (lurasidone) for the treatment of schizophrenia in adults. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for Latuda on January 23, 2014.
About 3.5 million people in Europe are currently living with schizophrenia which can have a huge impact on those affected, their families and caregivers.1 Symptoms can be diverse and include hallucinations, distorted reality, depression and social withdrawal. Schizophrenia is also associated with shortened life expectancy of 10-22.5 years,2,3 which can in part be due to the undesirable effects of antipsychotics such as weight gain, increased blood pressure and increased blood sugar.4,5 The leading cause of mortality for people with schizophrenia is cardiovascular disease5 – an estimated 75% die from this versus a general population mortality rate of 50%.6
Prof. Hans-Jürgen Möller, Direktor der Uni-Psychiatrie München said, “We know 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. 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.”
The Marketing Authorization was based on a comprehensive clinical trial program of eight positive studies, which included placebo and active comparators. The review also contained more than 50 clinical trials and more than 4,500 lurasidone-treated subjects. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia.7,8,9,10,11 In short and long term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change.9,10,12 It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.5
Lurasidone demonstrated a statistically significant separation from placebo seen as early as day four on primary efficacy measures in some of the pivotal trials in schizophrenia.7 The most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, parkinsonism and dystonia.13
Clinical studies 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.14,15,16,17
Lurasidone demonstrated significant reductions in mean weight and BMI over 12 months in contrast to increases in risperidone-treated patients.12 In separate studies, lurasidone demonstrated significant reduction in clinically significant weight gain (≥ 7%) compared to quetiapine XR over 12 months18, and patients switching from olanzapine to lurasidone experienced mean weight loss during the subsequent 6 months.19
“Lurasidone is the DSP Group’s core product for global expansion, and I am very pleased that we have achieved the important milestone of the approval of lurasidone for schizophrenia in Europe,” said Masayo Tada, President and Chief Executive Officer of DSP. “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.”
“We are very pleased with the marketing authorization of lurasidone in the European Union,” said Yasuchika Hasegawa, president & CEO of Takeda. “We believe lurasidone represents an important new treatment option for people in Europe living with schizophrenia. This milestone also enhances our central nervous system franchise, one of our core therapeutic areas.”
Latuda will be marketed in the UK by Sunovion Pharmaceuticals Europe Ltd., a subsidiary of DSP, and across Europe by Takeda subsidiaries.
SOURCE: Takeda Pharmaceutical Co
Post Views: 81
