VCBeat Health Contact Us
Home FDA Approves GSK’s Nucala (Mepolizumab) 40 mg Prefilled Syringe for At-Home Treatment of Severe Eosinophilic Asthma in Children Aged 6–11

FDA Approves GSK’s Nucala (Mepolizumab) 40 mg Prefilled Syringe for At-Home Treatment of Severe Eosinophilic Asthma in Children Aged 6–11

Jan 25, 2022 04:22 CST Updated 04:22
GSK

Pharmaceutical R&D Manufacturer

FDA

U.S. Food and Drug Administration


News on January 24, 2022 /BioValleyBIOON/ --GlaxoSmithKline PLC.(GSK) recently announced that the U.S. Food and Drug Administration (FDA) has approved anti-inflammatory drugsNucala (mepolizumab) 40mg Prefilled SyringeExpanded Applicable Population:Inclusion of 6-11 years old with severe eosinophilicAsthma(SEA) Pediatric Patients. Now, this injector can be administered by healthcare providers or by caregivers at home who have been trained by medical professionals. Nucala is an add-on prescription maintenance therapy for patients aged 6 years and older with SEA.

Nucala is administered via subcutaneous injection once every 4 weeks. Previously, children aged 6-11 with SEA in China required treatment with Nucala in a hospital setting, where doctors had to reconstitute the lyophilized powder formulation of Nucala.This latest approval will allow these pediatric patients to be treated at home using pre-filled syringes.The child health care provider will determine whether it is appropriate to administer the medication at home. If so, they will instruct the patient’s caregiver on how to properly administer the medication and monitor for any allergic reactions.

Asthma is the most common chronic disease in children. It is estimated that 6 million children in the United States have asthma. Approximately 2.5-5% of these cases are severe asthma. Severe asthma affects the quality of life of patients, and despite high-dose standard treatment, patients' asthma symptoms remain uncontrolled. This increases the burden on patients.AsthmaRisk of an episode.

Tonya Winders, CEO and President of the Allergy and Asthma Network and President of the Global Allergy and Airways Patient Platform, stated: "Patients with severe eosinophilicAsthmaYounger populations often experience more symptoms, have less control over these symptoms, and face more frequent exacerbations, making daily activities challenging for children. Additionally, for many, visiting the doctor's office for biologics can be a challenge, so having Nucala treatment at home offers more flexibility for both children and caregivers."

Mechanism of Action of Nucala (Image Source: gskpro.com, click the image to view larger)

Nucala was first approved at the end of 2015 for the treatment of severe eosinophilic conditions.Asthma(SEA), the world's first biologic therapy targeting IL-5 to be globally launched. The active pharmaceutical ingredient in Nucala, mepolizumab, is a monoclonal antibody that specifically targets interleukin-5 (IL-5). IL-5 is a cytokine that regulates the growth, activation, and survival of eosinophils (a type of white blood cell) and provides critical signaling for the migration of eosinophils from the bone marrow to the lungs and other organs.

Nucala binds to human IL-5, blocking the binding of IL-5 to the receptor on the surface of eosinophils. Inhibiting the binding effect of IL-5 on the receptor in this way can reduce the levels of eosinophils in the blood, tissues, and sputum, which in turn can reduce the inflammation mediated by eosinophils. Based on this mechanism of action, Nucala is being developed for various diseases caused by inflammation due to eosinophils. The drug has been approved in 41 countries.Clinical Trial、More than 4,000 patients across various eosinophil-related indications have been evaluated.

As of now, Nucala has been approved in the United States for the treatment of four eosinophil-driven diseases: (1) severe eosinophilic...Asthma(SAE, ≥6 years); (2) Treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA, adults); (3) Treatment of Hypereosinophilic Syndrome (HES, ≥12 years); (4) Treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP, adults).

In China, Nucala was approved in November 2021 for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).(Bioon.com)