Equity
Good news for Richter, share price jumps
Great news by Richter
Richter and Allergan today announced that the FDA has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.Vraylr is also approved in the U.S. to treat manic or mixed episodes associated with bipolar I disorder in adults. There are nearly 11 million adults in the U.S. living with bipolar disorder,1 a condition that causes extreme shifts in mood, energy, and activity levels.
Treating bipolar disorder can be very difficult because people living with the illness experience a range of depressive and manic symptoms, sometimes both at the same time, and this FDA approval gives healthcare providers a new option to treat the full spectrum of bipolar I disorder symptoms, specifically manic, mixed, and depressive episodes, with just one medication," said Dr. Stephen Stahl, Professor of Psychiatry at the University of California San Diego and lead author of the post hoc analysis, Cariprazine Efficacy in Patients with Bipolar Depression and Concurrent Manic Symptoms.
“Treating depression, mania and mixed episodes with a single medication is important for people living with, and healthcare providers treating, this complex illness. This approval can streamline a treatment decision while helping to stabilize the disorder."
The FDA approval for the expanded indication of Vraylar is based on three pivotal trials, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating scale (MADRS) total score. In all three studies, the Vraylar 1.5 mg dose demonstrated statistical significance over placebo; additionally, the Vraylar 3 mg dose demonstrated statistical significance over placebo. Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.
“This approval represents an important milestone in our efforts to help patients and prescribing healthcare providers effectively manage bipolar I disorder and demonstrates our ongoing focus on mental health," said David Nicholson, Chief Research & Development Officer at Allergan.
“We are committed to developing therapies for complex mental health disorders including Vraylar which is currently in phase III clinical trials for the treatment of Major Depressive Disorder," he added.
“This approval is considered a notable achievement in the development process of cariprazine, our flagship product," said Dr. István Greiner, Research Director of Gedeon Richter Plc. “We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option."
Share price jumps
Shareholders are happy about the report; Richter’s share price jumped by more than 5% today, but it is still nearly 3% lower than at the end of 2018.
