The committee reviewed data from a comprehensive clinical program comprising eight studies. Results from the clinical trials showed greater symptom improvement in Zyprexa long-acting injection (LAI) treated patients, compared with those on placebo. Due to the nature of the formulation of Zyprexa LAI, supplementation with oral antipsychotics was not needed to achieve or maintain effect in these studies.
John Hayes, vice president of Lilly Research Laboratories, said: “Due to the chronic and severe nature of the illness and the limited number of approved long-acting formulations, we believe that, if approved, Zyprexa LAI could be an important treatment option for this patient population, who struggle with taking their medication.”