Genentech/Novartis Xolair goes before advisory committee

Executive Summary

Asthma treatment Xolair (omalizumab) will go before FDA's Pulmonary-Allergy Drugs Advisory Committee on May 15. Genentech and Novartis are seeking an indication for treatment of moderate-to-severe allergic asthma in adolescents and adults. The firms narrowed the requested indication after FDA deemed the number of patients studied for a younger age group and an allergic rhinitis indication to be insufficient in a July 5, 2001 "complete response" letter. The meeting will be held at the Holiday Inn in Gaithersburg, Md. beginning at 8 a.m. [To watch a 1webcast of this meeting and other meetings, go to FDAAdvisoryCommittee.com]...