The European Commission on Ist Of August had granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. This is the only monthly dose anti-IL5 biologic approved in Europe that patients with severe eosinophilic asthma can self-after getting it prescribed by a pulmonologists. The original lyophilised version remains available, giving doctors a choice of three different administration options to best fit in with their patients’ lives.
“Making Nucala available for patients to take in the convenience of their own home is an major and significant step that builds on its proven efficacy, reflecting our ongoing efforts to meet the needs of patients with complex diseases.” Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, commented in an exclusive interview with Thailand Medical News.
Patients suffering from severe eosinophilic asthma usually experience life-changing impacts, experiencing asthma symptoms that remain uncontrolled despite high-dose standard treatments. This can leave them struggling to breathe and at increased risk of a potentially fatal asthma attack.
Severe asthma is classified as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller ie systemic corticosteroids, to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this protocol. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils, a category of white blood cells, is known to cause inflammation in the lungs. The cytokine 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. Research suggest that about 62% of patients with severe asthma have eosinophilic airway inflammation.
was first approved in 2015by the US FDA 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, reducing blood eosinophils without completely depleting them.
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 21 clinical trials across a number of eosinophilic indications and is the only drug with 4.8 years of safety and efficacy data in severe eosinophilic asthma (SEA). Mepolizumab is 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 SEA. It is also the only anti-IL-5 biologic approved for paediatric use from ages six to 17 in Europe in SEA. In the US, Japan, Canada and a number of other markets, it is also approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA).
In Europe, Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. Nucala 100mg solution for injection in pre-filled pen and pre-filled safety syringe are only appropriate for use by adults and adolescents aged 12 years and over and are prohibited for administration to children aged 6 to 11 years old. This age group should be t
reated with the lyophilised powder (40mg) for solution for injection.
Nucala is contraindicated in patients with hypersensitivity to mepolizumab or to any of the excipients. Nucala should not be used to treat acute asthma exacerbations.
Asthma-related adverse symptoms or exacerbations may occur during treatment with the drug. Patients should be instructed to consult their doctors if their asthma remains uncontrolled or worsens after initiation of treatment. Abrupt discontinuation of corticosteroids after initiation of Nucala therapy is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the direction of a doctor.
Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset.These reactions may occur for the first time after a long duration of treatment.
Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections should be treated for the helminth infection before starting therapy with Nucala. If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, injection site reactions and back pain. Headache was considered very common. Common adverse drug reactions include lower respiratory tract infection, urinary tract infection, pharyngitis, hypersensitivity reactions (systemic, allergic), nasal congestion, upper abdominal pain, eczema, back pain, administration-related reaction (systemic, non-allergic), local injection site reactions, and pyrexia. Severe allergic reactions (anaphylaxis) is a rare side effect .Injection site reactions (e.g., pain, erythema, swelling, itching, and burning sensation) occurred at a rate of 8% in subjects treated with Nucala .