At the beginning of August 2019, GSK received approval from the EMA for two new dosage forms of mepolizumab: The IL-5 antibody can now also be administered as a pen and a pre-filled syringe. It is thus the only fixed-dose, four-weekly anti-IL-5 biologic available for treatment in severe eosinophilic asthma, even for patient self-injection outside the office.
In two open-label, single-arm Phase III studies, it was shown in a “real-world” scenario that, after appropriate training by healthcare professionals, 89-95% of patients were able to successfully self-administer the pen injection; the success rate for the injection was as high as 100%. Another open-label parallel group study confirmed that the pharmacokinetics and pharmacodynamics of Nucala administered by pen or pre-filled syringe were comparable to the previously approved lyophilizate.
“Patients with severe refractory asthma often find it difficult to cope with everyday life, so regular visits to the doctor can be an additional burden,” explained Prof. Karl-Christian Bergmann, MD, Berlin. “The new dosage forms of mepolizumab give the treatment team and the patient greater flexibility in therapy. The treatment setting can now be individually adapted to the patient’s needs and possibilities in joint consultation.”
Mepolizumab is approved for add-on therapy of severe eosinophilic asthma associated with elevated blood eosinophil counts >150 µm/ml. Eosinophilic asthma generates about four times the cost per patient as asthma in general. About four out of ten people with severe asthma are hospitalized each year due to an asthma attack.
Mepolizumab is the first monoclonal antibody in its class to target IL-5. It is thought to act by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibition of IL-5 binding reduces blood eosinophils. In addition, mepolizumab is the only anti-IL-5 therapy approved in the form of the lyophilizate for solution for injection in Europe for use in children and adolescents aged 6 to 17 years for severe eosinophilic asthma. Nucala 100 mg solution for self-injection by pen and pre-filled syringe are approved only for adults and adolescents 12 years of age and older.
InFo PNEUMOLOGY & ALLERGOLOGY 2019; 1(2): 33 (published 9/26/19, ahead of print).
