First Appro Of Sertindole In UK; Launch Imminent

Danish drugmaker Lundbeck has received approval to market its atypical antipsychotic drug sertindole in the UK. The company said that supplies have been laid in and the launch of the drug, under the trade name Serdolact, will take place in the next few days. This is the first world approval for sertindole, one of a new generation of neuroleptics with advantages over typical compounds.

Lundbeck filed its Product License Application in the UK on December 18, 1995, and Claes Cordsen, the company's international product manager for new products and antipsychotics, admitted that the firm has been caught a little by surprise by the speed of the approval. The UK is acting as rapporteur for the rest of the European Union under the decentralized drug approval procedure. Other member states now have three months to review the dossier, and it seems likely that further approvals could be forthcoming before year-end.

Sertindole is indicated for the treatment of acute and chronic schizophrenia and schizo-affective disorders and psychoses including positive and negative symptoms. The drug should not be used for urgent relief of symptoms in acutely disturbed patients, according to the Summary of Product Characteristics. It is given once daily, starting at 4mg/day and then increased by 4mg increments each three-to-four days to the optimum dose range of 12-20mg/day. The maximum daily dose is 24mg.