FDA grants supplemental nda for Allergan, Gedeon Richter’s VraylarMay 29, 2019
UPDATE: The original article’s fifth paragraph was cut off at “demonstr”. The article has been updated with the conclusion of the fifth paragraph, and two more paragraphs.
Allergan and Gedeon Richter got the U.S. Food and Drug Administration approval for 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.
Vraylar is also approved in the U.S. to treat manic or mixed episodes associated with bipolar I disorder in nearly 11 million adultsin the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.
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 said 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.
David Nicholson, Chief Research & Development Officer at Allergan said the company will continue developing therapies for complex mental health disorders, including Vraylar, which is currently in Phase 3 clinical trials for the treatment of major depressive disorder.
Allergan said in the press release that the FDA approval for the expanded indication of Vraylar is based on three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56, 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, in RGH-MD-54, 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.
David Nicholson, Chief Research & Development Officer at Allergan, said: “We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in Phase 3 clinical trials for the treatment of major depressive disorder.”
Dr. István Greiner, Research Director of Gedeon Richter Plc, said: “This approval is considered a notable achievement in the development process of cariprazine, our flagship product. We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option.”