Panel Backs New Form of Lilly Schizophrenia Drug

(February 6, 2008) -- SILVER SPRING, Md., Feb 6 (Reuters) - A U.S. advisory panel on Wednesday backed Eli Lilly and Co's proposed long-acting form of schizophrenia drug Zyprexa.

Advisers to the Food and Drug Administration said the experimental injectable formulation appeared effective and had acceptable safety, despite a risk of severe sedation.

About 1 percent of patients treated with the drug in Lilly's studies experienced excessive sedation within three hours of an injection, including two cases described as comas. All patients recovered fully within three days.

Panel members said the risk was acceptable for certain patients and the injectable version could control symptoms in people who fail to take oral medications for the disease regularly.

"I believe there are large numbers of patients who would significantly benefit by having this drug available to them," said panel member Barbara Wells, dean of pharmacy at the University of Mississippi.

But the panel stressed the long-acting version would not be appropriate for all schizophrenic patients. Many advisers said it should be reserved for people with a known history of failing to take oral therapies as prescribed.

"We want to avoid casual use of the drug," said Dr. Matthew Rudorfer, the panel chairman and a researcher at the National Institute of Mental Health.

The committee voted unanimously in favor of the drug's effectiveness, and 10-0 with one abstention that the risks were acceptable for treating stable patients as well as those with acute symptom flare-ups.

The FDA will consider input from the panel, a group of outside experts, before deciding whether to approve the drug. The agency usually follows panel recommendations.

Zyprexa is Lilly's top-selling drug with nearly $4.8 billion in 2007 sales. The company currently sells a once-a-day pill version, plus a short-acting injection for acute agitation. The proposed long-acting injection is called Zyprexa Adhera.

Jon LeCroy, an analyst at Natixis Bleichroeder said approval was expected "simply because schizophrenia is such a tough disease to treat."

He estimates annual sales of $550 million by 2012, but said peak sales could top $1 billion.

Schizophrenia is a chronic mental illness that impairs the ability to think clearly, relate to others and distinguish between reality and fantasy. More than 2 million Americans have schizophrenia, according to U.S. government estimates.

As many as 65 percent of schizophrenics do not take their medicines as prescribed, which can lead to a relapse of symptoms, Lilly said.

Zyprexa Adhera injections would be given every two or four weeks.

Lilly said the exact cause of excessive sedation was uncertain, but it appeared to occur after injections into a muscle hit a blood vessel and sent the drug rapidly into circulation.

The company proposed that prescribing instructions advise patient monitoring for at least one hour after an injection. The company also said it would conduct a 5,000-patient study to try to better understand the sedation risk.

Other potential side effects, such as weight gain and elevated blood sugar, appear similar with the injectable and oral versions, FDA reviewers said.

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Known generically as olanzapine, Zyprexa is part of the class known as atypical antipsychotics that were introduced in the 1990s. Zyprexa Adhera would compete with Johnson & Johnson's long-acting schizophrenia injection called Risperdal Consta.

Two older schizophrenia drugs also are sold in the United States in long-acting injectable forms.

Source: Reuters

Last updated: 02/08

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