FDA Approves Genentech's Xolair (omalizumab) Prefilled Syringe Formulation
South San Francisco, CA -- September 28, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the U.S. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.
“Xolair has long been an important treatment option for people with allergic asthma and CIU,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The prefilled syringe formulation reflects our continued commitment to provide healthcare professionals with choices to best support each patient's unique needs."
The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.
Xolair is approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. Over 330,000 people in the U.S. have been treated with Xolair since its initial approval for people 12 years and older with allergic asthma in 2003.
About allergic asthma and chronic idiopathic urticaria
Asthma is a serious and chronic lung disease affecting an estimated 26 million people in the U.S. It causes swelling and narrowing of the airways, making breathing difficult. Allergic asthma, the most common form of asthma, accounts for approximately 60 percent of asthma cases in adults.
Chronic idiopathic urticaria (CIU) is a skin condition that can cause hives and severe itch that can last many months and years. CIU is characterized by hives that spontaneously occur without an identifiable cause, and recur for six weeks or more. It is estimated that approximately 1.5 million people in the U.S. have CIU.
About Xolair
Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.
In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair. Genentech is a leading biotechnology company that discovers, develops, manufacturers and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies.
About Xolair Access Solutions
Patients experiencing financial hardship may be eligible to receive coverage and reimbursement support for Xolair. Patient assistance and informational resources are available through Xolair Access Solutions (http://www.xolair.com/allergic-asthma/xolair-access-solutions.html).
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Source: Genentech
Posted: September 2018
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Xolair (omalizumab) FDA Approval History
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