Roche’s asthma med Xolair has scored approval from the US Food and Drug Administration (FDA) for the treatment of nasal polyps in adults.
Xolair (omalizumab) has been approved as an add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older, who have not responded well to nasal corticosteroids.
The approval is based on results from the phase III POLYP 1 and POLYP 2 trials, which showed that adult nasal polyps patients with inadequate response to standard treatment who received Xolair had greater improvements at week 24 in Nasal Polyp Score (NPS) compared to placebo.
“With today’s approval, people living with nasal polyps now have a treatment option that targets IgE, an underlying driver of various allergic conditions,” said Levi Garraway, chief medical officer and head of global product development, Roche.
“We are committed to understanding the full potential of Xolair across the spectrum of allergic diseases and are excited to provide this important treatment for people living with nasal polyps,” he added.
Xolair targets and blocks immunoglobulin E (IgE), which is a key driver of inflammation. It is also approved to treat moderate to severe persistent asthma and for chronic idiopathic urticaria (CIU).