FDA Approves Xolair (Omalizumab) for Nasal Polyps in Adults Unresponsive to Nasal Corticosteroids

Compiled by Hemingway

On December 1, Genentech, a member of the Roche Group, and Novartis simultaneously announced that the U.S. FDA had approved Xolair, which is jointly developed and commercialized by the two companies.^®(Omalizumab) Supplemental Biologics License Application (sBLA) for the adjunctive maintenance treatment of nasal polyps in adult patients aged 18 years and older who are insufficiently responsive to intranasal corticosteroids.

Following FDA approval, omalizumab became the only antibody approved in the United States for targeting and blocking immunoglobulin E (IgE). By reducing free IgE, downregulating high-affinity IgE receptors, and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade. This mechanism of action suggests that Xolair may have therapeutic potential across all relevant allergic diseases. The approval of this treatment indication for patients with nasal polyps represents a significant step forward in the exploration of Xolair for allergic, respiratory, inflammatory, and related conditions.

This FDA authorization is based on the results of the Phase III POLYP 1 and POLYP 2 clinical trials. POLYP 1 and POLYP 2 are replicate Phase III clinical studies designed to evaluate the efficacy and safety of omalizumab versus placebo in adult patients with nasal polyps who have an inadequate response to nasal corticosteroids.

Both trials were randomized, multicenter, double-blind, placebo-controlled clinical studies. POLYP 1 enrolled 138 patients, and POLYP 2 enrolled 127 patients. The results of both trials demonstrated that in adult patients with nasal polyps who had an inadequate response to intranasal corticosteroids, treatment with omalizumab led to statistically significant improvements in the Nasal Polyp Score (NPS) and the mean weekly Nasal Congestion Score (NCS) at Week 24 compared with the placebo group.

In both studies, greater improvements in NPS and NCS were observed in the omalizumab group compared with the placebo group as early as the first assessment at Week 4. During the treatment period and the five-week run-in phase, all patients received intranasal corticosteroid therapy with mometasone to eliminate background effects. The clinical trial results for POLYP 1 and POLYP 2 were published in the recent issue of the Journal of Allergy and Clinical Immunology.

No new or unexpected adverse reactions were observed in patients treated with omalizumab, and more than 95% of patients completed each endpoint assessment in the POLYP 1 and POLYP 2 trials. The most common adverse reactions (occurring in ≥3% of patients) included headache, injection site reactions, arthralgia, upper abdominal pain, and dizziness.

Omalizumab was first approved in 2003 for the treatment of moderate-to-severe asthma. It is also the first biologic agent approved for the treatment of chronic idiopathic urticaria, and the first drug approved for this indication since non-sedating H1-antihistamines. Currently, it has marketing approvals for two formulations and three indications. [Related Reading: Food Allergies Can Be Prevented! Genentech’s Xolair Receives Breakthrough Therapy Designation]

As a prescription medication administered via subcutaneous injection, it has been approved for the treatment of:

For patients aged 6 years or older with moderate-to-severe persistent asthma whose symptoms are not controlled by inhaled corticosteroid therapy, skin or blood tests are conducted to determine whether the patient is allergic to perennial allergens.

Patients aged 12 years and older with chronic idiopathic urticaria (CIU; chronic urticaria of unknown cause) whose urticaria persists despite treatment with H1 antihistamines.

Since its initial approval for allergic asthma in 2003, omalizumab has been used to treat approximately 460,000 patients in the United States.

References:

1.Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps

2.Novartis announces FDA approval of Xolair® (omalizumab) for adults with nasal polyps