Novartis (NYSE:NVS) has announced that the US FDA has approved its Xolair® (omalizumab) prefilled syringe for self-injection supplemental Biologics License Application for treatment of patients in all approved indications in the US. Currently, Xolair is the only FDA-approved biologic that has been designed to block and target immunoglobulin E (IgE) for treating moderate to severe persistent allergic Asthma, nasal polyps, and chronic idiopathic Urticaria (CIU).
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Victor Bulto, Novartis Pharmaceutical Corporation President, said that the FDA approval for Xolair is a massive milestone for the company, and it highlights its continued commitment to innovations since the first approval in 2003. Bulto stated that the new offering of self-injection for Xolair will give healthcare providers additional administration alternatives for patients, which is ideal considering the unprecedented times due to the pandemic.
Interestingly, before a patient starts self-injection with Xolair prefilled syringe, they should have no history of anaphylaxis, and a healthcare provider should observe the patient closely for three injections to ascertain there are no allergic reactions (hypersensitivity. Also, after initiation of Xolair therapy and safety established in a healthcare setup, the healthcare provider can determine the appropriateness of Xolair self-injection in a prefilled syringe by caregiver or patient.
Notably, the healthcare provider should train the caregiver or patient on the right subcutaneous injection technique and acknowledge anaphylaxis signs and symptoms and the necessary treatment for anaphylaxis before the self-injection outside the healthcare setting.
Xolair approval massive milestone for the patient community
Asthma and Allergy Foundation of America CEO and President Kenneth Mendez said that expansion of treatment alternatives for self-management and personalized care is welcome news to patients. He said that the possibility of administering an FDA-approved treatment outside the healthcare provider’s office is a huge milestone that could minimize barriers to care and caregivers. Since 2003, around 460,000 patients have received Xolair treatment across CIU, asthma, and nasal polyps. Xolair’s use across the indications is based on a safety and efficacy profile supported by a sting clinical development program that includes ten Phase III studies.