Recently, Eli Lilly (LLY) received US Food and Drug Administration (FDA) approval for Zyprexa Relprevv (olanzapine), the new extended release injectable version of its blockbuster drug Zyprexa for the treatment of schizophrenia in adults. The new version carries its own patent and may act as a cushion to Zyprexa’s sales when the main patent expires in 2011. However the approval comes with the requirement of patient monitoring by health care professionals for three hours after they get the injection to watch for signs of mild to severe sedation or delirium. 

With respect to treatment option, the approval is significant as the Zyprexa Relprevv injection maintains therapeutic drug levels for up to four weeks, when the disease relapses following irregular intake of prescribed medications. Long acting treatments play a beneficial role since non-adherence to medication is a big problem for the patients. 

The FDA approval is based on data from a trial involving 2,054 patients. Zyprexa Relprevv was found to be effective in controlling symptoms of schizophrenia. This is approved in the European Union under the trade name Zypadhera and in New Zealand and Australia under the trade name Zyprexa Relprevv. 

Schizophrenia is a mental illness affecting about 2.4 million Americans or about 1.1% of the adult population in the US. Although symptoms of schizophrenia can be treated, it is usually a lifelong condition requiring continued treatment. 

Earlier this month, Lilly received FDA approval for supplemental New Drug Applications (sNDAs) for Zyprexa (in tablet form) for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents of 13-17 years of age. 

Zyprexa was initially approved by the FDA in 1996 and launched in 2000 for the treatment of acute bipolar mania. Subsequently, the drug received approval for additional indications including schizophrenia and bipolar maintenance. Zyprexa belongs to a class of drugs called atypical antipsychotics, approved for the long-term treatment of schizophrenia. Zyprexa has been a major contributor to Lilly’s top line, with sales of $1.22 billion during the third quarter of 2009, up 3% compared to the year ago period.
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