PHILADELPHIA - GlaxoSmithKline plc (GSK) today announced that the US Food and Drug Administration (FDA) has approved a 40 mg prefilled syringe of Nucala (mepolizumab) for appropriate children aged 6 to 11 years old who have severe eosinophilic asthma (SEA).

Nucala can now be given by a child's health care provider or administered at home by a caregiver once trained by a health care professional. Nucala is an add-on, prescription maintenance treatment for patients 6 years and older with severe eosinophilic asthma.

Previously, children aged 6 to 11 years old received a dose of 40 mg Nucala using a solution that was mixed and administered in a physician's office. Now, a child's healthcare provider will determine if at-home administration is appropriate, and if so, will provide instruction to a patient's caregiver on how to properly administer and monitor for any allergic reactions. Nucala will be administered every four weeks whether at home or in the physician's office.

Asthma is the most common chronic disease in children.[i] It is estimated that 6 million children in the US are living with asthma.[ii] Approximately 2.5-5% of these cases are characterized as severe.[iii],[iv] Severe asthma can have an impact on a patient's quality of life, as their asthma symptoms can remain uncontrolled, despite high-dose standard treatments.[v],[vi] This can leave patients at an increased risk of asthma attacks.[vii]

'The younger population with severe eosinophilic asthma often has more symptoms, less control over those symptoms and experiences more frequent exacerbations, making childhood activities challenging,' said Tonya Winders, CEO & President, Allergy and Asthma Network and President of Global Allergy and Airways Patient Platform. In addition, she emphasized 'for many, going to the doctor's office to receive a biologic can be challenging, so having the possibility for children to receive Nucala at home, provides a bit more flexibility for the child's and caregiver's lives.'

'The needs of our patients and physicians continue to be the driving force of our innovation and new treatment offerings in the respiratory space,' said Dr. Tom Corbridge, GSK U.S. Senior Medical Lead. 'Being able to provide a treatment option administered at home for patients as young as 6 years old who are living with severe eosinophilic asthma, is an example of how our commitment to the community combined with clinical excellence can deliver on those needs.'

Through ongoing research, GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating to address the unmet needs in this patient group.

About Nucala (mepolizumab)

Nucala (mepolizumab) is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus. First approved in 2015 for SEA, Nucala was the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels. The mechanism of action for mepolizumab has not been definitively established.

Nucala is available as a solution in a prefilled syringe, prefilled autoinjector and as a lyophilized powder that comes in a vial and is reconstituted for injection for in-office use. If their healthcare professional determines that it is appropriate, people with SEA (adults and pediatrics aged 6 years and older) and their caregivers can administer Nucala at home, after training by a health professional.

Nucala has been developed for the treatment of diseases that are driven by inflammation associated with eosinophils. It has been studied in over 4,000 patients in 41 clinical trials across several eosinophilic indications and has been approved in the US, the EU and in over 25 other markets, as an add-on maintenance treatment for patients with SEA. Mepolizumab is approved in 17 markets, including the EU and US, for pediatric use in SEA from ages six to 17 years of age, with approval in an additional seven markets for use in patients with SEA aged 12-17 years. The first approval for mepolizumab in chronic rhinosinusitis with nasal polyps (CRSwNP) was granted by the FDA in July 2021. Mepolizumab is approved for use in patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a total of 14 markets including the US, Japan and Canada. Mepolizumab was first approved for use in hypereosinophilic syndrome (HES) in the US in September 2020 and approvals have since then been granted in an additional 5 markets.

In addition, mepolizumab is being studied in patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype and it is not currently approved for use in COPD anywhere in the world.

About severe asthma and severe eosinophilic asthma

Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming uncontrolled or which remains uncontrolled despite this therapy. Severe asthma patients can also be defined by the need for maintenance use of oral corticosteroids (OCS).[viii]

SEA is characterized by having an increase of eosinophils, a type of white blood cell that helps fight disease and infections. However, in some people, a high number of eosinophils can have a negative effect and is associated with inflammation of the airways, potentially resulting in asthma symptoms.6

About GSK

Lyndsay Meyer

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

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