The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in a Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD). AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year. According to MedPage Today, 44%…
AbbVie and Gedeon Richter unveil neuropsychiatric alliance
AbbVie (NYSE:ABBV) and Gedeon Richter have formed a co-development and license agreement focused on novel dopamine receptor modulators with the potential to treat neuropsychiatric diseases. Lake Bluff, Illinois-headquartered AbbVie and Budapest, Hungary-based Gedeon Richter have already collaborated for 15 years in central nervous system projects, including the development of cariprazine (Vraylar/Reagila), which is now authorized to…
AbbVie files supplemental New Drug Application with FDA for cariprazine
AbbVie (NYSE: ABBV) has submitted a supplemental New Drug Application (sNDA) for cariprazine (Vraylar) for major depressive disorder (MDD). FDA first approved cariprazine for schizophrenia and bipolar disorder in 2015. Current indications of the drug cover the acute treatment of manic or mixed episodes related to bipolar I disorder and depressive episodes associated with bipolar…