Minerva Neurosciences Announces Update on its NDA for the Treatment of Negative Symptoms in Schizophrenia
Minerva Neurosciences, Inc. recently announced that following the Type A meeting held on November 30, 2022, the US FDA has confirmed the refuse to file letter dated October 14, 2022 remains in effect in respect of the company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
“We are very disappointed to announce that the FDA has confirmed that it will not file our NDA for roluperidone for the treatment of negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “We will continue to work with the FDA regarding their feedback and assess the next steps for roluperidone.”
Schizophrenia is a chronic, severe, and debilitating type of mental illness characterized by distortions in thinking, perception, emotions, language, sense of self and behavior. Schizophrenia affects 20 million people worldwide. (World Health Organization).
Negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure. Negative symptoms are characterized by five constructs: blunted affect, alogia, avolition, anhedonia, and asociality (Marder and Galderisi, 2017).
Negative symptoms are the main cause of the poor functional outcome of patients suffering from schizophrenia (Harvey et al., 2020) and may also be one of the main reasons ultra-high risk adolescents may develop full blown schizophrenia (Gomes and Grace, 2017). There are currently no treatments approved for negative symptoms of schizophrenia in the US.
Minerva believes that research continues to emerge indicating that there is a large subgroup of patients with schizophrenia who have moderate to severe primary negative symptoms and minimal positive symptoms (Galderisi 2021) and have a low risk of worsening of positive symptoms even in the absence of antipsychotic treatments (Harrow 2013; Moilanen 2016; Murray 2016; Wils 2017; Wunderink 2013; Landolt 2016).
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. Our goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone (MIN-101), in clinical development for negative symptoms of schizophrenia, and MIN-301 for Parkinson’s disease. For more information, visit our website.
Total Page Views: 686
