FDA Approves Novartis/Roche’s Xolair Prefilled Syringe for Self-Injection Across All Indications

April 13, 2021 News /BioonBIOON/ --Novartis(Novartis) recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (BLA) for Xolair (Chinese brand name: Zhuole; generic name: omalizumab), provided in pre-filled syringes, offering a new self-administration option for all indications already approved in the United States. Previously in the U.S., Xolair was approved for administration by healthcare providers in clinical settings. It is the only biologic agent approved to target and block immunoglobulin E (IgE) for the treatment of moderate-to-severe persistent allergicAsthma, chronic idiopathic urticaria (CIU), nasal polyps.

NovartisVictor Bulto, President of Novartis US, stated: “TodayFDA"The approval represents an important milestone for Xolair and underscores our ongoing commitment to patient innovation since the initial approval of Xolair in 2003. With the introduction of a new self-injection option for Xolair, healthcare providers can now offer additional administration options for appropriate patients—a choice that is particularly timely given the COVID-19 pandemic."

Before initiating self-injection with the Xolair prefilled syringe, patients must have no history of hypersensitivity and must be closely observed by a healthcare provider for at least three injections without experiencing any allergic reactions. Once Xolair therapy has been initiated and safely established in a healthcare setting, the healthcare provider may determine whether it is appropriate for the patient or caregiver to administer self-injections using the Xolair prefilled syringe. Prior to the first self-injection outside of a healthcare facility, the healthcare provider must train the patient or caregiver on proper subcutaneous injection technique, how to recognize the signs and symptoms of an allergic reaction, and how to appropriately treat an allergic reaction.

In the United States,NovartisCo-developed and co-promoted Xolair with Genentech, a member of the Roche Group. Since its initial approval in 2003, approximately 460,000 patients in the United States have received treatment with Xolair for allergic conditions.Asthma, CIU, and nasal polyps, demonstrating favorable efficacy and safety profiles, and is supported by a robust clinical development program (including 10 Phase III studies).

Xolair is the only approved anti-IgE antibody medication that specifically targets, binds to, and blocks IgE. By reducing free IgE levels, downregulating high-affinity IgE receptors, and limiting mast cell degranulation, Xolair minimizes the release of mediators during the allergic inflammatory cascade. This prescription drug is administered via subcutaneous injection and has been approved in numerous countries worldwide for the treatment of moderate-to-severe persistent allergicAsthma(SAA), chronic spontaneous urticaria (CSU), and chronic idiopathic urticaria (CIU). In addition, the Xolair pre-filled syringe has been approved for marketing in many countries worldwide. In the US market, the drug is jointly developed and promoted by Novartis and Genentech, a member of the Roche Group, while markets outside the United States are handled byNovartisResponsible for sales and record-keeping.

In August and December 2020, Xolair was approved in the European Union and the United States for a new indication: as an add-on therapy to intranasal corticosteroids (INC) for the treatment of adult patients (≥18 years) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled with INC. Phase III studies demonstrated that Xolair reduced nasal polyp size (as defined by the Nasal Polyp Score [NPS]) and improved symptoms and quality of life in patients with CRSwNP.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic disease that often co-occurs with other respiratory conditions, severely impairing patients’ quality of life. Its symptoms include persistent nasal congestion, difficulty breathing and sleeping, and loss of smell. Notably, Xolair is the first therapy specifically targeting and blocking IgE for the treatment of CRSwNP, with IgE being a key driver in the inflammatory pathway of this disease. The approval and market launch of Xolair will provide a new treatment option for patients with CRSwNP in Europe whose condition is inadequately controlled with intranasal corticosteroids (INC), significantly improving their symptoms and quality of life.

In China, Xolair (Chinese brand name: Zhuole; generic name: omalizumab) was approved in August 2017 for the treatment of patients aged 12 years and older with moderate-to-severe allergic asthma that is not adequately controlled with inhaled corticosteroids combined with long-acting β2-adrenergic agonists. This approval makes Xolair (Zhuole) the first approved therapy in China for the treatment ofAsthma's first targeted therapy drug. (Bioon.com)

Original Source: Novartis receivesFDA approval of Xolair (omalizumab) self-injection with prefilled syringe across all indications for appropriate patients