Allergan’s Vraylar wins U.S. FDA approval for bipolar depression
By Manojna Maddipatla
May 28 (Reuters) – Allergan Plc’s Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, expanding its scope of treatment to a full spectrum of symptoms related to the condition, the company said on Monday.
Vraylar, which recorded a 70.3% sales jump in the first quarter, is an approved treatment in the United States for schizophrenia in adults and for manic or mixed episodes associated with bipolar I disorder.
The drug is expected to bring in sales of $683 million in 2019 and rake in sales of about $1.36 billion by 2026 with the label expansion, Mizuho analyst Irina Koffler said.
“The company has a long legacy in depression. This is more just building on the strength that they already have,” Koffler had said before the drug’s approval.
Allergan’s drug pipeline has come under increased investor scrutiny after the clinical failure of its depression treatment candidate, rapastinel, which some analysts had considered a potential blockbuster.
Allergan’s falling share price and increasing competitive challenges for top-selling Botox and Restasis, combined with rapastinel’s failure, prompted some investors to call for drastic measures from the drugmaker, including splitting the roles of chairman and chief executive officer.
Allergan, however, continues to build on its long-standing strength in the mental health space.
In addition to testing Vraylar in autism and as an add-on treatment for major depressive disorder, the company is developing other medications for depression and Alzheimer’s disease, Allergan’s research and development chief David Nicholson told Reuters.
There are nearly 11 million American adults living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.
Reporting by Manojna Maddipatla and Saumya Sibi Joseph in Bengaluru; Editing by Anil D’Silva