GSK gets FDA nod for 2 methods of administering Nucala

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GSK gets FDA nod for 2 methods of administering Nucala

By Sandra Levy - 06/07/2019
GlaxoSmithKline has received the Food and Drug Administration’s approval for 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 U.S. 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 or the rare disease eosinophilic granulomatosis with polyangiitis, or 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.

“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,” Hal Barron, chief scientific officer and president, R&D, GSK, 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,” Tonya Winders, president, Global Allergy and Asthma Patient Platform said.

It is expected that the new administration options for Nucala will be available in the United States shortly.

First approved in 2015 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.

In the U.S., Nucala (100-mg fixed dose subcutaneous injection of mepolizumab) is licensed as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala (3x 100mg subcutaneous injection of mepolizumab) is licensed for the treatment of adult patients with EGPA.