GSK rhinosinusitis drug receives thumbs up from the FDA

09-Sep-2021 - Last updated on 09-Sep-2021 at 17:40 GMT

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Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.

GlaxoSmithKline has announced that the US Food and Drug Administration (FDA) has granted approval to the company’s Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), as a treatment for patients diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). The new indication for the treatment is designed for add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older that have not experienced an adequate response to nasal corticosteroids.

According to GSK, CRSwNP is found in up to 4% of the US population, or more than 5m people. Chronic symptoms can include nasal obstruction, loss of smell, facial pressure, and nasal discharge.

GSK reports that mepolizumab is the first anti-IL-5 biologic to be approved for adult patients with CRSwNP in the US. Outsourcing-Pharma talked about the drug’s development and approval with US mepolizumab lead Jared Silver, who said its approval offers hope to chronic CRSwNP patients that have been suffering from symptoms.

“There really have been limited options, and there tend to be less effective therapeutic options for more severe disease,” he said. “The standard of care can include saline rinses, sometimes steroid sprays; others go on to oral steroids, which can have more toxicity and adverse events. More severe patients go on to require surgery, which usually entails endoscopically removing diseased tissue.”

Tonya Winders—CEO and president of the Allergy and Asthma Network (AAN) and president of Global Allergy and Airways Patient Platform—agreed that Nucala’s approval offers a welcome expansion to the limited options for CRSwNP treatment.

“Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities,” she said. “We welcome the news that mepolizumab will now offer appropriate patients and healthcare providers a novel treatment option and alternative to surgery.”

Silver added that the therapeutic benefits of mepolizumab fall in four ways:

reducing symptoms and polyp burden
elevating quality of life
avoiding the need for surgery
eliminating exposure to potentially harmful steroids.

The dosage is 100mg subcutaneously injected once a month. Patients have the option of receiving the injection from their physician at their office, or at home with an auto-injector.

The FDA’s approval of mepolizumab to treat CRSwNP is based on data from the SYNAPSE study, which examined the drug’s effect compared to that of a placebo in more than 400 patients with the condition. According to GSK, mepolizumab achieved significant improvement in reducing the size of nasal polyps and nasal obstruction; all study participants received standard care, had previously undergone surgery (some more than three surgeries), and had been diagnosed as being in need of additional surgery due to symptom severity and polyp size.

Mepolizumab is also approved for use for patients with severe eosinophilic asthma 6 years and older. The treatment also was the first biologic indicated for adults with eosinophilic granulomatosis with polyangiitis (EGPA), and the first biologic to be approved for patients aged 12 years and older with hypereosinophilic syndrome (HES).