Shares of Rockville-based Vanda Pharmaceuticals Inc. lost more than half their price in Monday morning trading after the company announced that its lead drug candidate had been rejected by the Food and Drug Administration.
Regulators said Vanda’s schizophrenia drug candidate, called iloperidone which it hoped to brand as Fanapta, was “not approvable” — a harsh blow to the company that its officials and some analysts have described as surprising and one that leaves Vanda scrambling to figure out its next steps.
In a letter to the body, the FDA acknowledged that Fanapta acted similarly to another schizophrenia drug on the market, ziprasidone, labeled as Geodon by Pfizer Inc., in a clinical trial the local company passed in December 2006, unit that had sent Vanda’s dullard price soaring at the time.
But the agency before-mentioned it wanted Vanda to conduct further clinical tests on how Fanapta compared by another schizophrenia drug being sold on pharmacy shelves, citing in particular risperidone, marketed during the time that Risperdal by Johnson & Johnson, and olanzapine, marketed as Zyprexa by Eli Lilly & Co.
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