(1998; 18 pages)
Sertindole - approval application withdrawn
Abbott, United States of America. Abbott Laboratories has voluntarily withdrawn its New Drug Application from the US Food and Drug Administration for the anti-schizophrenia agent, sertindole, licensed from H. Lundbeck A/S of Denmark.
In trials involving more than 2,000 patients up to June 1996, 27 patients died whilst receiving sertindole, including 13 sudden deaths. Although there was no proof that the drug actually caused these deaths, there was no explanation for them. Sertindole is known to induce QT interval prolongation in some patients. Other antipsychotics have been associated with QT interval prolongation, and sudden death has been associated with schizophrenia. Sertindole is safer and better tolerated than some other neuroleptics, e.g. it has low rates of extrapyramidal symptoms compared to haloperidol.
The company is carrying out further evaluation of clinical trials already under way, including a trial in treatment-resistant patients.
Sertindole has already been approved in 19 European countries and is marketed in 12 countries under the name SerdolectR. Lundbeck is conducting a pan-European Phase IV study involving 4,000 sertindole- prescribed patients with schizophrenia and 8,000 patients receiving other atypical anti-schizophrenia therapies.
Reference: Marketletter February 2, 1998.