H. Lundbeck A/S announced today that it has not yet received an action letter from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for Serdolect® (sertindole) for the treatment of schizophrenia. The company anticipated receipt of the action letter on May 15, 2009, the originally assigned Prescription Drug User Fee Act (PDUFA) date. The FDA informed the company that they would receive the action letter as soon as possible.
Serdolect derives from Lundbeck’s in-house research and the company holds the global rights. It has a unique neuropharmacological profile, characterised by inhibitory effects on dopamine D2, serotonin 5-HT2 and 5-HT6 receptors, as well as on alpha1-adrenergic receptors. Serdolect has a high limbic selectivity, indicating antipsychotic activity without potential for extrapyramidal motor side-effects. It has no effect on muscarinic cholinergic and histamine H1 receptors, which could be associated with cognitive and sedative side-effects. The preclinical profile has been confirmed in clinical trials.
The content of this release will have no influence on the Lundbeck Group’s financial result for 2009.