Roche Submits sBLA to FDA for Xolair Prefilled Syringe Enabling Self-Administration Across All Approved Indications

August 14, 2020 /BioValleyBIOON/ -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (Chinese brand name: Zhuole; generic name: omalizumab), applicable to all indications already approved for the drug in the United States.FDAAn approval decision is expected in the first quarter of 2021. In the United States, Xolair is currently approved for administration by healthcare providers in healthcare settings and is the only biologic agent approved to target and block immunoglobulin E (IgE) for the treatment ofModerate to Severe Persistent AllergicAsthmaandChronic Idiopathic Urticaria (CIU)。

Levi Garraway, M.D., Chief Medical Officer and Global Head of Product Development at Roche, stated, “Due to the COVID-19 pandemic, there is an urgent need to provide our patients with self-administration options for Xolair, particularly those considered at high risk for severe disease. We look forward to working withFDA“Work closely together and launch the Xolair self-administration option as soon as possible, providing patients with greater flexibility to manage their treatment needs.”

If approved, once Xolair therapy has been established and is under close monitoring by healthcare providers, self-administration of Xolair pre-filled syringes by patients or caregivers outside of a healthcare setting may be deemed appropriate for selected patients. In such cases, patients or caregivers will receive training from healthcare providers on proper subcutaneous injection techniques and on recognizing the early signs and symptoms of anaphylaxis.

In the United States, Genentech, a member of the Roche Group, andNovartisCo-develop and co-promote Xolair.Since the first approval of Xolair for the treatment of allergic asthma in 2003, approximately 460,000 patients in the United States have received Xolair therapy. The use of Xolair in allergic asthma and chronic idiopathic urticaria (CIU) is supported by a robust clinical development program, which includes eight Phase III studies, including those on allergicAsthmaIndependent clinical studies in patients with chronic idiopathic urticaria (CIU) have demonstrated that Xolair can be self-administered with appropriate training and monitoring.

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 co-developed and promoted by Genentech, a member of the Roche Group, in collaboration with Novartis; markets outside the United States are handled byNovartisResponsible for sales and record-keeping.

Earlier this month, Xolair was approved in the European Union 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 of the inflammatory pathway in this disease. The approval of Xolair will provide a new treatment option for patients in Europe with CRSwNP whose condition is not adequately controlled by 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 receptor agonists. This approval makes Xolair (Zhuole) the first biologic therapy approved in China for the treatment ofAsthmathe first targeted drug. (Bioon.com)

Original Source:FDA accepts application for Xolair (omalizumab) prefilled syringe for self-administration across all indications