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The CHMP's positive opinion is now referred for final action to theEuropean Commission, which grants approval in the European Union. TheCommission usually makes a decision on CHMP recommendations within two tothree months.
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Olanzapine LAI is an investigational formulation that combines Zyprexa(R)(olanzapine), an atypical antipsychotic, with pamoic acid resulting in a saltthat sustains the delivery of olanzapine for a period of up to four weeks.Earlier this month, olanzapine LAI was approved for use in New Zealand.Independent regulatory reviews of olanzapine LAI applications forschizophrenia are ongoing in the United States, Canada, Australia and othercountries.
Since olanzapine was introduced in 1996, it has been prescribed to morethan 26 million people worldwide. Long-acting injectables have been associatedwith improved treatment for patients who struggle with adherence to oralmedications.(i)
"Because of the chronic and severe nature of schizophrenia, persistentchallenges with adherence and the limited number of depot formulationsavailable, we believe that olanzapine LAI has the potential to become avaluable treatment option for patients," said David McDonnell, M.D., clinicalresearch physician at Lilly. "We look forward to making olanzapine LAIavailable in the European Union in the near future."
The CHMP opinion was based on a comprehensive data package comprisingeight studies, involving 2,054 patients, including a double-blind,placebo-controlled, fixed-dose study (HGJZ)(ii); a double-blind, oralolanzapine-controlled, fixed-dose study (HGKA)(iii); and six open-labelstudies. In these trials, olanzapine LAI was found to be similar to olanzapineoral in terms of rate of symptom exacerbation and showed a similar safetyprofile as the oral formulation with the exception of injection-relatedevents, including Post-Injection Delirium/Sedation Syndrome (PDSS).(iv)
As of August 31, 2008, across all clinical trials, PDSS events, includinga range of symptoms of sedation (from mild in severity to unconsciousness)and/or delirium (including confusion, disorientation, agitation, anxiety andother cognitive impairment), have been seen in 0.07 percent of injections and1.4 percent of patients, all of whom have recovered fully.(v)
As part of the marketing authorization in Europe, Lilly has proposed acomprehensive risk minimization plan for identifying and managing PDSS. Theplan includes a requirement for a post-injection observation period describedin the product labeling, and an extensive healthcare provider training andeducational program.
Notes for editors:
About Long-acting Injectable Antipsychotic Medications
The World Federation of Societies of Biological Psychiatry (WFSBP)guidelines state that poor or partial treatment compliance is a major problemin the long-term treatment of schizophrenia. Depot formulations should beconsidered as a treatment option when a patient expresses a preference forsuch treatment due to convenience or if it is determined that a depotformulation is necessary to help with compliance.(vi)
Long-acting antipsychotic formulations have been associated with improvedtreatment adherence and reduced treatment failures.(vii) By administeringlong-acting medications, healthcare professionals know when patients havereceived their medication and can immediately detect non-adherence when apatient fails to return for a scheduled injection.(viii) Different from bothoral and injected short-acting formulation
