Lilly Highlights Symbyax Onset Of Action; Other Bipolar Presentations At APA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Lilly is highlighting a rapid onset of action and lack of treatment-emergent mania for its olanzapine/fluoxetine combination Symbyax, currently pending at FDA for the treatment of bipolar depression.
You may also be interested in...
Zyprexa and Seroquel add bipolar claims
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...
Lilly Symbyax complete response
Lilly submits complete response during second quarter to an "approvable" letter for its olanzapine/fluoxetine combination Symbyax, the firm says July 24. Lilly "expects final FDA approval in 2004"; the NDA was submitted in fourth quarter 2002. The firm is highlighting the combo's rapid onset of action (1Pharmaceutical Approvals Monthly June 1, 2003, p. 5)...
GSK Lamictal Bipolar Claim "Approvable"; Exact Indication Under Discussion
GlaxoSmithKline is discussing the scope of a bipolar indication for Lamictal following an April 4 "approvable" letter for the new claim.