GSK’s Nucala gets FDA approval

Positive data from two phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala (mepolizumab), self-administered via autoinjector or a pre-filled safety syringe in-clinic and/or at home, has led to the FDA granting approval for GSK’s drug, rendering it the first anti-IL5 biologic to offer a choice of how and where a patient living with severe eosinophilic asthma or eosinophilic granulomatosis with polyangiitis can receive treatment. The studies demonstrated that patients successfully self-administered both the autoinjector (89-95%) and pre-filled syringe (100%) after appropriate training, and that most patients preferred to self-administer at home rather than in-clinic.
President of global allergy and asthma patient platform, Tonya Winders, said: “People living with conditions like severe asthma often struggle to control their day-to-day symptoms, making routine activities like attending healthcare appointments a challenge. Empowering patients to take their medicines at home is an approach that has been successful in other chronic diseases such as diabetes and rheumatoid arthritis. GAAPP welcomes this approval for Nucala so it can be administered in a doctor’s office or in the convenience of a patient’s home.”