Novartis/Roche Xolair Prefilled Syringe Receives FDA Approval

 

On April 12, the FDA approved a supplementary biological product license application for Xolair (omalizumab) prefilled syringes, which can be used for self-injection and are suitable for all indications approved in the United States. The syringe was developed by Genentech, a subsidiary of Novartis and Roche.

Xolair is a biological agent that targets and blocks immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU), and nasal polyps. It specifically targets and combines Block IgE. By reducing free IgE, down-regulating high-affinity IgE receptors, and limiting mast cell degranulation, Xolair can minimize the release of mediators during the sensitive inflammation cascade. It can minimize the release of mediators in the allergic inflammatory cascade.

This medicine is a prescription injection drug that is administered by subcutaneous injection. Since it was first approved in 2003, approximately 460,000 patients in the United States have received Xolair treatment. Xolair has good efficacy and safety in the treatment of allergic asthma, CIU, and nasal polyps, and is supported by strong clinical development projects (including 10 phase III studies).

Xolair was approved for the treatment of nasal polyps in December last year as an add-on therapy to intranasal corticosteroids (INC) for the treatment of severe chronic rhino-sinusitis with nasal polyps that cannot be adequately controlled by INC. ( CRSwNP) adult patients (≥18 years old). The Phase III study showed that Xolair reduced the size of nasal polyps (as defined by the nasal polyp score [NPS]) and improved the symptoms and quality of life of CRSwNP patients.

Before starting self-injection with Xolair prefilled syringes, the patient must have no history of allergies and be closely observed by the healthcare provider for at least three injections, and no allergic reactions have occurred. After Xolair treatment has begun and is safely established in a medical environment, the healthcare provider can determine whether it is appropriate for the patient or caregiver to use Xolair prefilled syringes for self-injection. Before performing the first self-injection outside the medical institution, the healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of an allergic reaction, and how to properly treat the allergic reaction.