In an interview with PharmaShots, Tom Corbridge, Senior Medical Lead at GSK shared his views on the approval of its anti-IL-5 biologic NUCALA (mepolizumab) in a 40 mg pre-filled syringe for appropriate children aged 6 to 11 years old with severe eosinophilic asthma (SEA)

Shots:

• Nucala can now be given by a child’s HCPs or administered at home by a caregiver once trained by a health care professional. It is an add-on, prescription maintenance treatment for patients 6 years and older with severe eosinophilic asthma.
• The new indication will provide children with the opportunity to have their asthma treated from the comfort of their home by a trained caregiver or healthcare professional
• Nucala was the FIC mAB 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. 

Tuba: Discuss on severe eosinophilic asthma along with its epidemiology.

Tom: 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).

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.

The exact cause is unknown, although high levels of eosinophils are often associated with the chronic airway inflammation and obstruction in severe asthma, resulting in increased symptoms and exacerbations.

A simple blood test can help identify people with asthma who have an eosinophilic phenotype. Blood eosinophil levels can be measured through a complete blood count (CBC) with differential. The results can be used as a guide to initiate individualized treatment of severe asthma.

Tuba: Tell us about Nucala (mepolizumab) with its MoA, RoA, and dose

Tom: Mepolizumab, marketed under the brand name of Nucala, is the first-in-class monoclonal antibody that targets IL-5 (interleukin-5). IL-5 (interleukin-5) is the key chemical in our body responsible for controlling the number and activity of eosinophils. Mepolizumab reduces the levels of eosinophils in the body by binding to IL-5, inhibiting its activity. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining within normal levels. The mechanism of action for mepolizumab has not been definitively established.

Nucala is approved in the following doses:

Injection: 40 mg/0.4 mL, single-dose prefilled syringe or single-dose autoinjector

Injection: 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe

100 mg of lyophilized powder in a single-dose vial for reconstitution.

Tuba: What are the different indications in which Nucala is indicated for use?

Tom: Nucala is indicated and available in the US 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.

Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

Add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Tuba: Is there any ongoing study for mepolizumab in other indications?

Tom: Mepolizumab is being studied in patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype and not currently indicated for this use anywhere in the world.

Tuba: Enlist out the name of different countries where mepolizumab is approved for adult and pediatric patients.

Tom: Nucala has been studied in over 4,000 patients in 41 clinical trials across a number of eosinophilic-driven indications and has been approved under the brand name Nucala in the US, Europe and in over 25 other markets, as an add-on maintenance treatment for patients with SEA.

Nucala 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

Tuba: What is the aim behind this FDA’s extended approval for Home Administration in Pediatric patients?

Tom: For many, going to the doctor’s office to receive a biologic can be challenging so having the possibility to receive Nucala at home provides more flexibility for the child and caregivers’ lives.

Tuba: What steps/ programs is GSK planning to initiate to engage with paediatric patients (such as gamification etc.)?

Tom: We are planning to share information regarding the 40 mg prefilled syringe administration option with caregivers of appropriate paediatric patients in the coming months. GSK is committed to improving the lives of those living with severe eosinophilic asthma, continuously innovating to address the unmet needs in this patient group.

Tuba: What more in GSK’s pipeline in respiratory space?

Tom: You can find information on our pipeline here: https://www.gsk.com/en-gb/research-and-development/our-pipeline/?immunology-respiratory

Source: Freepik

About Author:

Thomas C. Corbridge, MD, FCCP, is a GSK medical expert and an emeritus physician and adjunct professor of medicine at Northwestern University, Feinberg School of Medicine in Chicago, Illinois. Dr. Corbridge received his medical degree from the University of Chicago Pritzker School of Medicine and has been in practice for over 30 years. Dr. Corbridge specializes in pulmonary and critical care medicine and is experienced in asthma, chronic obstructive pulmonary disease and general pulmonology.

Related Post: PharmaShots Interview: X4 Pharmaceuticals’ Paula Ragan Shares Insights on Mavorixafor for the Treatment of Multiple Immunosdeficiencies