Policy & Regulation
Genentech submits Xolair sBLA with FDA for the treatment of nasal polyps in adult patients
11 December 2019 -

Biotechnology company Genentech said on Wednesday that it has filed its supplemental Biologics License Application (sBLA) for Xolair with the US Food and Drug Administration (FDA) for the treatment of nasal polyps in adult patients 18 years of age and older.

The company added that the US FDA is expected to make a decision on approval of Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. by Q3 2020.

Xolair is an injectable biologic medicine designed to target and block IgE. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, it minimizes the release of mediators throughout the allergic inflammatory cascade, said the company.

Nasal polyps reportedly presents as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow.

Upon approval by the US FDA, the company's Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE).

This sBLA is based on results from the company's Phase III POLYP 1 and POLYP 2 trials, which showed Xolair met both co-primary and multiple secondary endpoints in treating adult patients with CRSwNP who have not adequately responded to intranasal corticosteroids. The safety profile in these trials were consistent with the known safety profile for Xolair, with no new unexpected safety signals identified.

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