Omalizumab
- Generic Name
- Omalizumab
- Brand Names
- Xolair, Omlyclo
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 242138-07-4
- Unique Ingredient Identifier
- 2P471X1Z11
- Background
Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .
- Indication
This drug is an anti-IgE antibody indicated for:
- Associated Conditions
- Chronic Idiopathic Urticaria, Moderate Asthma, Severe Asthma
- Associated Therapies
- -
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
- First Posted Date
- 2004-03-22
- Last Posted Date
- 2012-04-11
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 628
- Registration Number
- NCT00079937
- Locations
- 🇺🇸
Clinical Research Institute of Southern Oregon, Medford, Oregon, United States
🇺🇸Family Allergy and Asthma Center, PC, Atlanta, Georgia, United States
🇺🇸West Penn Allegheny General Health System, Pittsburgh, Pennsylvania, United States
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
- Conditions
- Asthma
- First Posted Date
- 2002-10-04
- Last Posted Date
- 2017-08-02
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 484
- Registration Number
- NCT00046748
Drug Development Updates
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