trending Market Intelligence /marketintelligence/en/news-insights/trending/851Ivoe0BZ6S9BTsjzSavA2 content esgSubNav
In This List

Allergan-Gedeon Richter bipolar disorder drug gets expanded US FDA nod

Blog

Insight Weekly: Ukraine war impact on mining; US bank growth slowdown; cloud computing headwinds

Blog

Insight Weekly: Cryptocurrency's growth; green bond market outlook; coal investors' windfall

Blog

Global M&A By the Numbers: Q1 2022

Blog

Insight Weekly: Challenges for European banks; Japan's IPO slowdown; carmakers' supply woes


Allergan-Gedeon Richter bipolar disorder drug gets expanded US FDA nod

The U.S. Food and Drug Administration approved Allergan PLC and Gedeon Richter PLC's Vraylar for treating depressive episodes associated with bipolar 1 disorder in adults.

The approval was based on three pivotal clinical trials called RGH-MD-53, RGH-MD-54 and RGH-MD-56, which all showed that Vraylar, or cariprazine, was better than placebo in alleviating depressive episodes.

Vraylar was previously approved by the U.S. regulator for treating manic or mixed episodes associated with bipolar 1 disorder in adults.

About 11 million adults in the U.S. are living with bipolar disorder, which causes shifts in mood, energy and activity levels, the companies said in a May 28 news release.

Budapest-based Gedeon Richter discovered and is co-developing Vraylar. The drug is licensed by Dublin-based Allergan in the U.S. and Canada.