GSK's Nucala Receives EU Approval for Two New At-Home Dosing Options in Severe Eosinophilic Asthma

Aug 02, 2019 13:33 CST Updated 13:33

GSK

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GSK Announces on August 1 That the European Commission Has Approved Two New Administration Options for Its Anti-Inflammatory Drug Nucala (mepolizumab): A Pre-filled Pen and a Pre-filled Safety Syringe. It Is the Only Once-Monthly Anti-IL-5 Biologic Approved in Europe, Allowing Patients or Caregivers to Administer the Medication at Home for the Treatment of Severe Eosinophilic Asthma (SEA), Following Healthcare Professional Assessment.

The original lyophilized formulation remains available, allowing healthcare professionals to choose from three different dosing regimens. GSK plans to launch the two new dosing regimens in the European market this month.

In Europe, Nucala is indicated as an add-on maintenance therapy for the treatment of severe refractory SEA in children, adolescents, and adults aged 6 years and older. It should be noted that the Nucala 100 mg pre-filled pen and pre-filled safety syringe are only suitable for adolescent and adult patients aged 12 years and older, while pediatric patients aged 6–11 years should be treated with the lyophilized powder formulation (40 mg).

In the United States, these two new dosing regimens were approved in early June this year for monthly home administration by patients or caregivers to treat severe eosinophilic asthma (SEA) and the rare disease eosinophilic granulomatosis with polyangiitis (EGPA). This approval makes Nucala the first anti-IL-5 biologic approved for home injection in the U.S. market, as well as the first respiratory biologic administered via an autoinjector.

The approval of the new Nucala dosing regimen is based on positive data from two real-world, open-label, single-arm, Phase IIIa clinical studies (NCT03099096, NCT03021304). These studies evaluated the practical use of Nucala with the new dosing regimen by patients with severe eosinophilic asthma (SEA) or their caregivers in both clinical and home settings. Both studies demonstrated that, after appropriate training, patients were able to successfully self-administer treatment using pre-filled pens and pre-filled safety syringes (success rates of 98% and 100%, respectively). Furthermore, compared to administration in a clinical setting, the majority (98%) of patients preferred administering the medication at home.

Another open-label, parallel-group, single-dose pharmacokinetic and pharmacodynamic study (NCT0314674) confirmed that the pharmacokinetic and pharmacodynamic profiles of Nucala administered via a pre-filled safety syringe or a pre-filled pen are comparable to those of the initially approved lyophilized formulation.

Nucala Pre-filled Pen

The active ingredient in Nucala is mepolizumab, a fully humanized monoclonal antibody that specifically targets interleukin-5 (IL-5). Mepolizumab binds to IL-5, thereby blocking its interaction with receptors on the surface of eosinophils. By inhibiting the binding of IL-5 to its receptors in this manner, mepolizumab reduces eosinophil levels in the blood, tissues, and sputum, which in turn decreases eosinophil-mediated inflammation.

Currently, Nucala is developed to treat diseases caused by inflammation driven by eosinophils. The drug has been studied in 21 clinical trials involving more than 3,000 patients across multiple eosinophilic indications, and it is the only biologic agent with 4.8 years of safety and efficacy data for severe eosinophilic asthma (SEA).

Nucala was first approved in late 2015 as the world’s first biologic agent targeting IL-5. Currently, the drug has been approved in the United States, Europe, and more than 20 other markets. GSK is currently evaluating Nucala for the treatment of hypereosinophilic syndrome, nasal polyps, and chronic obstructive pulmonary disease (COPD).

According to GSK’s recently released 2019 H1 performance report, Nucala’s sales grew rapidly, with global sales in the first half reaching £347 million, a 37% increase year-on-year.

Reference Source: Nucala Receives EU Approval for Self-Administration by Patients with Severe Eosinophilic Asthma

*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.