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| |  Zyprexa Receives Approvable Letter For Treatment Of Acute Mania In Bipolar Disorder INDIANAPOLIS, IN -- October 28, 1999 -- Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for the company’s antipsychotic medication Zyprexa® (olanzapine) for the treatment of acute mania associated with Bipolar I Disorder. The efficacy was established in trials with patients with Bipolar I Disorder, who currently displayed an acute manic or mixed episode with or without psychotic features. "There is a great need for new medications that effectively treat mania associated with bipolar disorder," said Gary Tollefson, M.D., Ph. D, president, neuroscience products, Eli Lilly and Company. "Lilly welcomes the FDA’s action today, and plans to continue to work closely with the FDA to secure, as soon as possible, final approval of olanzapine for this indication as quickly as possible." Bipolar disorder, also known as manic depressive illness, is a lifelong illness characterized by disruptive swings in mood-from manic episodes, marked by euphoria and irritability, to periods of depression. People with bipolar disorder also may experience mixed episodes, marked by simultaneous manic and depressive episodes. Mania is a period of abnormal elation and/or extreme irritability, often accompanied by an unrealistic belief in one’s own abilities, increased sex drive, and alcohol or drug abuse. Mania may include delusions that warrant hospitalization. Mania associated with bipolar disorder, while manageable with proper therapy, can be extremely difficult to diagnose and treat. Approximately three million Americans suffer from bipolar disorder. An estimated one in four persons with the illness attempt suicide, the highest incidence-rate for any psychiatric disorder. Research suggests that approximately 30 percent of people with bipolar disorder are misdiagnosed. Olanzapine is currently indicated in the United States for the management of the manifestations of psychotic disorders as demonstrated in short-term clinical trials involving patients with schizophrenia. Since its introduction in 1996, olanzapine has been prescribed for more than 3.5 million people worldwide. In the original registration trials, olanzapine was generally well-tolerated. However, as with all antipsychotics, olanzapine was associated with some side effects. In the original six-week, acute-phase trials, the most common treatment-emergent adverse event associated with olanzapine was somnolence. Other common events were dizziness, weight gain, personality disorder, constipation, akathisia and postural hypotension. Modest elevations of prolactin were also seen, although mean changes from baseline to endpoint were not statistically significantly different between olanzapine and placebo. A small number of patients experienced asymptomatic elevations of hepatic transaminase; none of these patients developed jaundice or drug-induced hepatitis.
Related Links: Zyprexa® (olanzapine) and Eli Lilly and Company.
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