Abbott Labs Withdraws Sertindole NDA

Abbott Laboratories has voluntarily withdrawn its New Drug Applicationfrom the US Food and Drug Administration for the anti-schizophrenia agent sertindole, licensed from H Lundbeck A/S of Denmark. Abbott had expected that the drug would be approved and had hoped to launch sertindole under the brand-name Serlect by end-1997 or early 1998.

While sertindole, a D2-, 5HT2- and alpha1-receptor antagonist, was deemed approvable by an FDA advisory panel in 1996 (Marketletter July 22, 1996), the committee also discussed the need to make patients aware of the risks associated with the product; about 4% of patients in trials experienced QT interval prolongation, an alteration of the heart's rhythm which can lead to sudden cardiac death.

Side Effects Of Sertindole Debated In trials involving more than 2,000 patients 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 the sudden deaths, and FDA cardiologist Raymond Lipicky told the panel in 1996 that, in his opinion, sertindole was "a dangerous drug."