Abbott's Serlect Still Waiting For Review

Although it was recommended for approval by a US Food and DrugAdministration advisory panel 16 months ago (Marketletter July 22, 1996), Abbott Laboratories' antischizophrenia agent Serlect (sertindole) is still waiting for final agency review.

Other antipsychotic agents have been approved in the interim, including Zeneca's Seroquel (quetiapine), and analysts now feel that even if the drug does come to market, its potential is much reduced. Robert Dunne of Wasserstein Perella commented that while the atypical antipsychotic probably will be approved, it will not be important to the company. Other analysts said that the problem may be that the panel, while recommending approval, also strongly suggested that patients need to know of its risks; about 4% of patients in trials experienced QT interval prolongation, ie an alteration of the heart's normal rhythm.

Abbott is still hopeful that the drug, licensed from H Lundbeck A/S of Denmark, will be approved. A company spokesman noted that Abbott had been in negotiations with the FDA on labeling for almost the entire period.