Further FDA Approval for Gedeon Richter Drug

The Hungarian pharma company Gedon Richter’s partner AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved VRAYLAR® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.

"When we were in the early stages of development for cariprazine, we focused on designing a compound that covers a range of symptoms for mental health conditions and affects the dopamine D3 receptor," István Greiner Ph.D., Research and Development Director of Richter said in a statement. "While schizophrenia and bipolar manic and mixed episodes were the first indications in the U.S. market, we are thrilled to see the full potential of cariprazine unlocked with approvals in bipolar I depression, and now, as an antidepressant adjunct in major depressive disorder," he added.

MDD is one of the most common mental disorders in the U.S.; approximately one in five adults will experience this disorder during their lifetime.1 In a large U.S. study of adults with MDD, approximately 50% still had depressive symptoms with their first antidepressant. If some symptoms of depression persist while on an antidepressant, adding a different type of medication, often referred to as an adjunctive treatment, to the existing regimen may help.

"Patients with inadequate response to standard antidepressant medication are often frustrated by the experience of trying multiple medicines and still suffering from unresolved symptoms. Instead of starting over with another standard antidepressant, VRAYLAR® works with an existing treatment and can help build on the progress already made," according to Gary Sachs, MD, clinical vice president at Signant Health, associate clinical professor of psychiatry at Massachusetts General Hospital, and lead Phase 3 clinical trial investigator. "For adults living with major depressive disorder, because of inadequate improvement in response to standard antidepressants, VRAYLAR® is an efficacious adjunctive treatment option with a well-characterized safety profile," he added.

Cariprazine is marketed as VRAYLAR® in the U.S., and in addition to being approved as an adjunctive therapy to antidepressants for the treatment of MDD in adults, it is FDA-approved to treat adults with depressive, acute manic and mixed episodes associated with bipolar I disorder, as well as schizophrenia. Cariprazine is co-developed by AbbVie and Gedeon Richter Plc. More than 8,000 patients worldwide have been treated with cariprazine across more than 20 clinical trials evaluating the efficacy and safety of cariprazine for a broad range of psychiatric disorders.

"Many living with major depressive disorder find that their ongoing antidepressant therapy doesn’t offer meaningful relief from the symptoms they experience every day," Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer at AbbVie highlighted. "Today’s approval of VRAYLAR® provides an important new treatment option to meet a critical unmet medical need. AbbVie is committed to driving progress and advancing solutions for patients living with complex neuropsychiatric conditions," he stated.