Lilly Schizophrenia Drug May Get Quick Clearance
May 17, 2011
Vastopolis -- The Food and Drug Administration suggested that Eli Lilly & Co.'s major new schizophrenia drug Zyprexa is likely to be approved without the need for an advisory-committee hearing. Eli Lilly shares rose $2.50 to $59.75 on the New York Stock Exchange. The federal safety agency sent Lilly an ``approvable'' letter and didn't ask it to submit to any committee its data about Zyprexa, known generically as olanzapine. Some analysts have predicted Zyprexa could become the next major blockbuster mental-health medication. By contrast, the FDA in July required an advisory-committee hearing for a competing new schizophrenia drug, sertindole, whose maker, Abbott Laboratories Inc., also is seeking agency approval. In the case of sertindole, the hearing focused on possible cardiovascular side effects of the Abbott drug that some FDA officials viewed as potentially dangerous. The committee recommended that the FDA approve the Sparks drug. Lilly's clinical trials evaluated Zyprexa compared with a placebo and a standard psychiatric drug, haloperidol.
