Zyprexa approved for bipolar disorder

Eli Lilly's market-leading schizophrenia drug Zyprexa has been granted European approval for the long-term treatment of bipolar disorder.

The approval makes it the first ever atypical antipsychotic to gain the new indication, and will consolidate its position as the biggest-selling product in the therapy area.

Already licensed to treat the acute mania phase of bipolar disorder, the new indication will allow doctors to also prescribe Zyprexa for the long-term prevention of further episodes.

Mauricio Tohen, Executive Director of Bipolar Disorders Studies at Eli Lilly said: "While Zyprexa is currently indicated for the acute mania phase, this endorses its use in the long-term prevention of relapsing into the manic, mixed manic or depressive episodes associated with bipolar disorder. Given the lifelong nature of the condition, maintaining wellness is what enables patients to have more productive lives."

The European Committee for Proprietary Medicinal Products (CPMP) based its approval on six studies in over 1550 patients with bipolar disorder. The positive opinion will be forwarded to the European Commission to issue marketing authorisation, anticipated later this year.

AstraZeneca's Seroquel and Janssen-Cilag's Risperdal are close behind Zyprexa in expanding into the treatment of patients with bipolar disorder, nearly one in five of whom commit suicide.

Both companies filed data in the US last December to support new licences, with Johnson & Johnson (Janssen-Cilag parent company) filing for both combination and monotherapy indications for its product.

Zyprexa has been approved in the US for use in combination with lithium or valproate (Abbott Depakote) for the treatment of acute bipolar mania, and is currently under FDA review as a monotherapy for long-term treatment.

Meanwhile, Symbax, a combination of Zyprexa with Prozac is also under US review for the condition.

AstraZeneca's Seroquel is the fastest growing of the rival products, with a 67% increase in 2002 sales earning it $1.15 billion, but Zyprexa remains well in the lead with sales of $3.7 billion last year.