MEDIA RELEASE

Greater flexibility for Australians with severe asthma with reimbursement of at-home, self-administration delivery of NUCALA^® (mepolizumab)

GSK Australia today announced that a new pre-filled pen (autoinjector) for the self-administration of its targeted therapy for severe eosinophilic asthma patients, NUCALA (mepolizumab), will be reimbursed by the Pharmaceutical Benefits Scheme (PBS) from 1 June 2020.

More than 2.4 million Australians are affected by asthma¹ and it is estimated up to 5-10% have severe asthma². Of patients with severe asthma, about 30% suffer from severe eosinophilic asthma³. These patients are now able to choose where they receive treatment – at home or via a healthcare professional.

A pre-filled pen (or autoinjector) is a disposable, spring-loaded medical device designed to deliver a specific dose of a medicine. The new pre-filled pen (autoinjector) for at-home administration will be an important option for those with severe eosinophilic asthma who may be unable to travel or attend a clinic to receive monthly treatment.

Severe eosinophilic asthma is a subtype of severe asthma, where there are too many eosinophils (a type of white blood cell) in the blood and lungs, causing inflammation and an increased risk of asthma flare-ups⁴. NUCALA works by reducing the number of these eosinophils and is given in addition to a patient’s regular preventer and symptom-controller medications. NUCALA is therefore an add-on treatment, for severe eosinophilic asthma patients aged 12 years and over, to help reduce the frequency of their asthma flare-ups and dose of oral steroids⁴.

Those affected experience debilitating symptoms such as wheezing, coughing, shortness of breath and frequent, life-threatening attacks⁵. This has a major impact on quality of life as it can impair a person’s independence and their ability to do everyday tasks like go to work, shopping, visiting the doctor or even walking short distances^5-6.

According to Professor Peter Gibson, respiratory physician and clinical researcher at the Hunter Medical Research Institute (HMRI), access to new self-administration options for severe eosinophilic asthma is a timely and positive development for Australian patients.

“Ensuring flexible treatment options for Australians living with severe eosinophilic asthma is an important step in reducing the burden of this disease,” said Professor Gibson.

“Access to treatments and ease of use are always important issues, particularly for patients in regional and remote areas. However, at a time when Australians have been self-isolating and spending more time at home, this new at-home administration option is especially significant. It may help facilitate greater continuity of treatment and protect vulnerable patients as they will not necessarily have to visit a clinic to access their regular treatment.”

Nearly 40% of adults with severe asthma are hospitalised at least once a year for the treatment of an asthma ‘flare-up’⁷, with duration of flare-ups lasting a few hours to a few days⁸.

Michele Goldman, CEO of Asthma Australia, said the reimbursement represents a step forward in reducing the burden of severe asthma on patients, their families and the healthcare system.

“The impact of severe eosinophilic asthma on the quality of life of patients and their families can be enormous. Debilitating symptoms and the risk of life-threatening attacks negatively impact those affected across all facets of their work and social life,” said Ms Goldman.

“Frequent visits to a healthcare professional to administer treatment are an added challenge for these patients. Innovations around self-treatment options may contribute towards helping patients with severe eosinophilic asthma reduce the burden of treatment on their lives and the overall burden on the healthcare system,” added Ms Goldman.

Dr Andrew Weekes, Medical Director at GSK Australia, said that this PBS listing is an important milestone for patients with severe eosinophilic asthma, enabling them to exercise more flexibility around how they receive their biologic treatment.

“GSK is pleased that Australians with severe eosinophilic asthma can now access a self- administration option for NUCALA via the PBS. The availability of the pre-filled pen will give patients greater choice around how they receive their biologic treatment and consider the setting that best fits their needs, in consultation with their healthcare professional,” said Dr Weekes.

“This latest development could be a progression for patients with severe eosinophilic asthma in taking greater control of their treatment, just as patients do with other chronic conditions such as diabetes. GSK is committed to bringing innovative solutions to the people that need them most and today’s announcement is evidence of that,” added Dr Weekes.

NUCALA was the first treatment reimbursed for severe eosinophilic asthma in Australia in 2017 on the Pharmaceutical Benefits Scheme.

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Maya Ivanovic                                    Martin Palin    
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About severe asthma and eosinophilic inflammation²

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 also commonly require long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the presence of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung.

About mepolizumab⁹

Nucala has made a significant impact on the lives of over 60,000 patients globally helping patients with severe asthma. First reimbursed in Australia in 2017 for severe eosinophilic asthma mepolizumab is 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. Inhibiting IL-5 binding in this way reduces blood eosinophils.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 16 clinical trials across a number of eosinophilic indications and has been approved (under the brand name Nucala) in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma. In Australia, mepolizumab is also approved as add-on treatment for relapsing or refractory eosinophilic granulomatosis with polyangitis (EGPA)9.

GSK’s commitment to respiratory disease

For 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world’s first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today’s industry-leading respiratory portfolio.

Important Safety Information for Nucala in Australia⁹

Nucala should not be used to treat acute asthma exacerbations.

The most commonly reported adverse reactions (>3% incidence) in phase III clinical trials with Nucala were headache, injection site reaction, back pain and fatigue. The most common symptoms associated with subcutaneous injections included pain, erythema, swelling, itching and burning sensation.

Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration with Nucala, with some having a delayed onset (i.e. days).

Pre-existing helminth infections should be treated prior to Nucala therapy.

In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in patients treated with Nucala versus none in the placebo group.

Healthcare professionals are advised to refer to the Full Product Information for further information regarding the safety of the product, including contraindications and precautions

Additional notes:

To access Nucala on the PBS, patients must meet specified criteria and be managed by a respiratory physician, clinical immunologist, allergist or general physician, experienced in the management of patients with severe asthma.

PBS Information: The 100 mg vial and 100 mg/mL pen are listed on the PBS as a Section 100 item. Refer to PBS Schedule for full authority information.

PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. The Product Information can be accessed at au.gsk.com/nucalapi

Nucala® (mepolizumab) Minimum Product Information

Indications: As an add-on treatment for severe eosinophilic asthma in patients aged 12 years and over (see CLINICAL TRIALS).

Contraindications: Hypersensitivity to mepolizumab or any of the excipients.

Precautions: Should not be used to treat acute asthma exacerbations. Asthma-related adverse events or exacerbations may occur during treatment. Patients should seek medical advice if asthma remains uncontrolled or worsens after initiation. Abrupt discontinuation of corticosteroids after initiation is not recommended. Acute and delayed systemic reactions, including hypersensitivity reactions (anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration, some had a delayed onset (i.e., days). Pre-existing helminth infections should be treated prior to Nucala therapy. Opportunistic infection with herpes zoster. Pregnancy: Category B1. Lactation: No data in human milk. Fertility: No data in humans. Paediatric use: Safety and efficacy in children under 12 years of age has not yet been established.

Interactions: No formal interaction studies have been performed with Nucala.

Adverse reactions: Headache, injection site reaction, back pain, fatigue, influenza, UTI, upper abdominal pain, pruritus, eczema, muscle spasms, pharyngitis, LRTI, nasal congestion, dyspnea, skin rash, fever, dizziness, nausea, vomiting, infection with herpes zoster. This is not a complete list, see full PI. Immunogenicity: patients may develop antibodies to mepolizumab following treatment.

Neutralising antibodies were detected in one subject in clinical trials.

Dosage and Administration: Adults and adolescents (12 years or older): recommended dose is 100 mg administered by subcutaneous injection (eg. upper arm, thigh, or abdomen) once every 4 weeks. Nucala powder for injection should be reconstituted and administered by a healthcare professional. Nucala solution for injection in a pre-filled pen (auto-injector) may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection technique (see full PI). Safety and efficacy not established in adolescents weighing less than 45kg. Not recommended in children below 12 years.

Nucala Min PI v4. For further details, please refer to the full PI.

Full Product Information is available at au.gsk.com/nucalapi. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. Nucala is a registered trade mark of the GSK group of companies. PI-5918 Date of approval: May 2020 Australian healthcare professionals can visit gskpro.com.au for more information on Nucala.

You can follow GSK on Twitter for more Australian updates @GSK_AU.