FDA Panel Gives Nod To Long-Acting Form Of Lilly’s Schizophrenia Drug Zyprexa
This article was originally published in The Pink Sheet Daily
Executive Summary
With appropriate label warnings, the excessive sedation side effect should not preclude approval of the atypical antipsychotic’s depot formulation.
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FDA's Psychopharmacologic Drugs Advisory Committee agreed Feb. 6 that the agency should approve Eli Lilly's Zyprexa (olanzapine) depot for acute and maintenance treatment of schizophrenia. In a unanimous vote with one abstention, panel members said Lilly could sufficiently offset the risk of excessive sedation seen with the new version of the atypical antipsychotic. Panel members suggested a risk management plan and label advising that patients first demonstrate non-adherence to oral olanzapine. The depot formulation of Zyprexa is known as OP Depot. The excessive sedation adverse event is unique to the new depot formulation, and relatively common, occurring in 1.2 percent of patients and .07 percent of injections. FDA concluded that the excess sedation was unpredictable, and that symptoms - including dizziness, confusion and coma - tend to be severe (1 (Also see "FDA Panel To Assess Excessive Sedation Linked To Lilly’s Zyprexa Depot Formulation" - Pink Sheet, 4 Feb, 2008.)). Despite the urging of some panel members toward more specifically precautionary language in labeling, FDA officials at the meeting expressed confidence in the ability of clinicians to prescribe the depot formulation to appropriate schizophrenic patients. "My presumption is that someone treating somebody makes a judgment and wouldn't use a depot unless the person was non-adherent," FDA's Office of Drug Evaluation I Director Bob Temple said. Division of Psychiatry Products Director Tom Laughren added that physicians would most likely not use the depot formulation as first-line treatment and suggested the labeling state that "given the risks of this drug, you might want to consider other options." The panel supported labeling proposed by Lilly calling for a three-hour post-injection precautionary period, including one hour of observation by a health care professional and the option of available support for the remaining two hours. Lilly also has proposed health care professional educational programs and educational materials for patients and caregivers. The oral, once daily formulation of olanzapine was first approved by FDA in 1996. The depot formulation is intended for administration every two to four weeks. -Jamie Hammon ([email protected]) |