Seroquel, launched in 1997, is one of AstraZeneca's top-selling drugs, with total sales of $2.8 billion last year. The drug is already used to treat acute manic episodes associated with bipolar disorder and schizophrenia, but the FDA approval adds the treatment of patients with depressive episodes.
With about 7 million adult Americans suffering from bipolar disorder, John Patterson, executive director of development for AstraZeneca, tells the AP, "Treating acute bipolar disorder with a single medication may help patients adhere to their medication regimen."
Previous anti-psychotic drugs had side effects giving patients tremors and restlessness. Newer drugs such as Seroquel, Eli Lilly and Co.'s Zyprexa, Johnson and Johnson's Risperdal and Bristol-Myers Squibb Co.'s Abilify are intended to have fewer side effects and dominate a market worth around $16.2 billion.
According to the report, the FDA decision to approve the new once-daily dose treatment in the United States was based on an eight-week study of 1,045 patients with bipolar depression.
Meanwhile, the FDA's approval helped push AstraZeneca shares 0.3 percent higher at 3,516 pence ($65.83) on the London Stock Exchange.
