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news.Eli Lilly and Company has announced that the Committee for Medicinal Products for Human Use has recommended European approval of olanzapine long-acting injection, known in Europe by the trade name Zypadhera, for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine.
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The Committee for Medicinal Products for Human Use’s (CHMP’s) positive opinion is now referred for final action to the European Commission, which grants approval in the EU. The commission usually makes a decision on CHMP recommendations within two to three months.
The CHMP opinion was based on a comprehensive data package comprising eight studies, involving 2,054 patients, including a double-blind, placebo-controlled, fixed-dose study; a double-blind, oral olanzapine-controlled, fixed-dose study; and six open-label studies. In these trials, olanzapine long-acting injection (LAI) was found to be similar to olanzapine oral in terms of rate of symptom exacerbation and showed a similar safety profile as the oral formulation with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS).
As part of the marketing authorization in Europe, Lilly has proposed a comprehensive risk minimization plan for identifying and managing PDSS. The plan includes a requirement for a post-injection observation period described in the product labeling, and an extensive healthcare provider training and educational program.
Olanzapine LAI is an investigational formulation that combines Zyprexa (olanzapine), an atypical antipsychotic, with pamoic acid resulting in a salt that sustains the delivery of olanzapine for a period of up to four weeks.
Earlier in September 2008, olanzapine LAI was approved for use in New Zealand. Independent regulatory reviews of olanzapine LAI applications for schizophrenia are ongoing in the US, Canada, Australia and other countries.
David McDonnell, clinical research physician at Lilly, said: “Because of the chronic and severe nature of schizophrenia, persistent challenges with adherence and the limited number of depot formulations available, we believe that olanzapine LAI has the potential to become a valuable treatment option for patients. We look forward to making olanzapine LAI available in the EU in the near future.”