GSK's Nucala Receives FDA Approval for First-at-Home Self-Administration in Severe Asthma Treatment
GSK
Pharmaceutical R&D Manufacturer
FDA
U.S. Food and Drug Administration
Recently, GlaxoSmithKline (GSK) announced that the U.S. FDA has approved a new mode of administration for its asthma therapy Nucala (mepolizumab). With this approval, Nucala has become the first anti-IL-5 biologic agent in the United States that can be self-administered at home.
This therapy targets severe asthma, which refers to cases where the condition is relatively severe and still requires a second controller medication despite treatment with high-dose glucocorticoids. In some patients with severe asthma, eosinophil overproduction has been observed, which is one of the causes of pulmonary inflammation. Underlying this process, IL-5 is a key factor promoting eosinophil growth.
As an IL-5 inhibitor, Nucala is a first-in-class monoclonal antibody therapy. By inhibiting IL-5, it is expected to reduce eosinophil growth and alleviate symptoms of severe asthma. In 2015, it was approved by the U.S. FDA for the treatment of severe asthma.
Image source: GSK official press release
However, in the past, patients had to visit hospitals for injections to receive treatment. To improve patients’ medication experience, GSK researchers have developed a new administration method by loading Nucala into a self-injection device, enabling patients or healthcare providers to administer injections every four weeks to control the disease. In two open-label, single-arm Phase 3a clinical trials, real-world data analysis revealed that patients could successfully learn how to self-administer injections after training. Another clinical trial demonstrated that the new administration method is similar to the previously approved dry powder formulation in terms of pharmacokinetics and pharmacodynamics.
“The efficacy of Nucala has been well validated. This approval also means that patients with severe asthma can use this important therapy at home for the first time,” said Dr. Hal Barron, Chief Scientific Officer and President of Research and Development at GSK.
References:
[1] Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options, Retrieved June 6, 2019, from https://www.businesswire.com/news/home/20190606005859/en/
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