http://www.cnn.com/2003/HEALTH/conditions/05/16/asthma.drug.ap/index.html

New asthma drug gets backing by FDA panel

Friday, May 16, 2003 Posted: 10:44 AM EDT (1444 GMT)

Story Tools HEALTH LIBRARY • Health Library  • Asthma  • Allergies  • Asthma and exercise  • Combination therapy for asthma

WASHINGTON (AP) -- A government advisory committee on Thursday recommended approval of a new drug for people with allergic asthma.

The committee voted 11-0 to endorse Xolair, a drug that takes a new approach by targeting proteins known as IgE antibodies that susceptible people produce in large numbers in response to allergens. Xolair binds to IgE antibodies in the blood and renders them inactive.

The final decision on whether to allow sale of the drug still must come from the Food and Drug Administration. The agency is not required to follow the recommendations of its advisory committees, but most often does so.

Dr. Karen Weiss of the FDA said the committee felt the drug was beneficial for patients that used in it trials.

The drug, developed by Genentech Inc. and Novartis Pharmaceuticals Corp., is taken by injection every two to four weeks.

The drug was first proposed for approval in 2001, but was delayed after the government asked for more information on possible side effects.

The recommended approval is limited to asthma caused by allergies and for people age 12 and over.