The US Food and Drug Administration (FDA) has accepted supplemental Biologics License Application (sBLA) to add a new self-administration option across all approved indications for Xolair (omalizumab).
Xolair is an antibody therapy designed to reduce sensitivity to allergens, by blocking immunoglobulin E (IgE), down-regulating its receptors and regulating mast cell degranulation.
The drug is being jointly developed and co-promoted by Genentech and Novartis Pharmaceuticals, in the US.
The current FDA filing acceptance follows the European Commission (EC) approval of Xolair for self-administration or administration by a trained caregiver, in all approved indications, granted in December 2018.
Novartis pharmaceuticals president Victor Bultó said: “Today’s FDA filing acceptance of Xolair is a big step forward for people living with IgE-mediated conditions.
“If approved, self-administration of Xolair would offer a new, convenient and flexible treatment administration option for patients and healthcare providers, which builds on the proven legacy, safety profile and efficacy of Xolair over the last 17 years of real-world use.
“This is in line with Novartis’ strong heritage of innovation and ongoing commitment to reimagining medicine and understanding the continually changing needs of patients and healthcare providers.”
The Phase 3 clinical studies showed that Xolair can be self-administered
Once approved, Xolair prefilled syringe is expected to be offered either for self-administration by select patients or administration by the caregivers. The FDA’s decision on approval is expected by the first quarter of 2021.
The prefilled syringe can be used outside of a healthcare setting by a patient or caregiver if considered appropriate by the healthcare provider for select patients.
In such cases, the patient or caregiver must be trained in subcutaneous injection technique and identifying early signs and symptoms of anaphylaxis, by a healthcare provider.
The drug is currently approved in the US, for patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU), to be administered by a healthcare provider in a healthcare setting.
Asthma is a chronic lung disease, characterised by swelling and narrowing of the airways, making breathing difficult. Allergic asthma is the most common type of asthma prevalence in around 60% of asthma cases in adults.
The approval and use of Xolair for allergic asthma and CIU are based on a clinical development program, including eight Phase 3 studies. The studies demonstrated that Xolair can be self-administered with proper training and monitoring.
