Zyprexa and Seroquel add bipolar claims
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly's Zyprexa receives approval for use as maintenance therapy for bipolar disorder Jan. 14, reclaiming its lead in indications within the atypical antipsychotic class. Zyprexa was the first atypical to gain an acute bipolar claim (in 2000), but other agents have either recently received or are pursuing the claim (1Pharmaceutical Approvals Monthly June 1, 2003, p. 5). AstraZeneca's Seroquel (quetiapine) is the latest to add acute use, with FDA approval Jan. 12. Janssen's Risperdal (risperidone) cleared FDA for acute bipolar use Dec. 4, 2003, while Bristol-Myers Squibb's Abilify (aripiprazole) and Pfizer's Geodon (ziprasidone) both have supplements pending. Lilly is also awaiting approval for Zyprexa IM; the company passed a pre-approval inspection for the intramuscular formulation in early December, which Lilly had said was the remaining hurdle to approval. The firm's Zyprexa/Prozac combo product, Symbyax (olanzapine/fluoxetine), was approved for bipolar depression Dec. 24, 2003. New indications and formulations are expected to reverse a recent decline in Zyprexa scripts, CEO Sidney Taurel told investors Jan. 13 at the J.P. Morgan Healthcare Conference...