GlaxoSmithKline announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate. This is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.
This approval will give healthcare professionals and people living with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA) the option for Nucala to be administered outside of a clinical setting by a patient or caregiver after their healthcare professional agrees this approach is appropriate. The original lyophilised powder version remains available for administration by a healthcare professional.
Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: "Nucala's efficacy is well-established and this approval means that, for the first time, we are able to provide patients living with these debilitating conditions the option of receiving this important medicine in their own home."
Tonya Winders, President, Global Allergy and Asthma Patient Platform (GAAPP), added: "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."
The approval is supported by positive patient experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers. Both studies showed patients were able to successfully self-administer treatment with both the autoinjector and pre-filled syringe after appropriate training (89-95% and 100% respectively). In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.
A further open-label, parallel-group, single-dose study (NCT03014674) confirmed that the pharmacokinetic and pharmacodynamic profile of Nucala administered via pre-filled syringe or autoinjector was comparable to the originally approved lyophilised formulation.
Following this approval, it is expected that the new administration options for Nucala will be available in the US shortly.
About severe asthma and eosinophilic inflammation
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 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 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. Studies suggest that approximately 60% of patients with severe asthma have eosinophilic airway inflammation.
About eosinophilic granulomatosis with polyangiitis (EGPA)
Eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss Syndrome, is a chronic rare disease that is caused by inflammation in the walls of small-to-medium sized blood vessels (vasculitis). Approximately five people out of every one million will be diagnosed with EGPA each year worldwide, with an estimated prevalence of approximately 14-45 per million. The mean age of diagnosis is 48 years, and the disease can be life-threatening for some patients. In EGPA, patients usually develop asthma initially, before the vasculitis extends to inflammation in the walls of small...
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