FDA Approves Autoinjector and Pre-filled Syringe for Self-Administration of Nucala

FDA Approves Autoinjector and Pre-filled Syringe for Self-Administration of Nucala

People who live in the U.S. and have eosinophilic granulomatosis with polyangiitis (EGPA) now can be treated with Nucala (mepolizumab) once every four weeks through at-home injections.

The U.S. Food and Drug Administration (FDA) recently approved an autoinjector and a pre-filled safety syringe as new methods to dose Nucala. Still, administration of the therapy with these tools has to be approved and prescribed by a healthcare professional.

This makes Nucala the first anti-IL5 biologic therapy to be licensed in the U.S. for at-home administration, allowing clinicians and patients to decide where they receive treatment, the therapy’s manufacturer GlaxoSmithKline, announced.

Following this approval, Nucala’s self-administration options are expected to be made available soon in the U.S.

“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, MD, chief scientific officer and president of research and development at GSK, said in a press release.

The FDA’s decision was based on clinical data from two open-label, Phase 3a studies (NCT03099096 and NCT03021304). These trials compared the real-world impact of using Nucala when administered via the new options in clinic and at home by patients with severe eosinophilic asthma (SEA), a respiratory illness for which Nucala also is approved.

Both studies showed that 89–95% patients were able to successfully self-administer Nucala when using the autoinjector, and 100% successfully used the pre-filled syringe, after appropriate training. Also, the majority of patients reported preferring the at-home self-administration options compared to going to the clinic.

Another Phase 3 clinical study (NCT03014674) compared the overall stability and delivery effectiveness of the therapy when dosed with the new methods or with the originally approved powder formulation. Collected data confirmed that Nucala’s pharmacokinetic (how the drug moves through the body) and pharmacodynamic (the effects of the drug) profiles remained within therapeutic ranges regardless of the administration method used.

“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,” said Tonya Winders, president pf the Global Allergy and Asthma Patient Platform (GAAPP).

“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,” she added.

Nucala was first approved in the U.S. in 2015 as treatment for SEA, and in 2017 as add-on therapy for patients with EGPA.

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