GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) for the treatment of hypereosinophilic syndrome (HES), a rare and under-diagnosed disorder.
Nucala has been approved to treat adult and paediatric patients aged 12 years and older with HES ≥ six months without an identifiable non-haematologic secondary cause.
Mepolizumab, the first-in-class monoclonal antibody that targets IL-5, first secured approval in 2015 to treat severe eosinophilic asthma (SEA).
Nucala is claimed to be the first and only targeted biologic treatment secured approval for patients with the eosinophil-driven disease in the US.
The approval of Nucala is based on positive data from a pivotal phase 3 study, which recruited 108 patients.
The 32-week, randomised, double-blind and placebo-controlled study has been designed to evaluate the efficacy and safety of subcutaneous mepolizumab 300mg every four weeks compared with placebo in patients aged 12 years and older with uncontrolled HES.
According to the company, the study demonstrated 50% fewer patients experienced a HES flare when treated with Nucala and compared to placebo, as well as when added to standard of care treatment over the 32-week study period.
At present, Nucala is indicated as an add-on maintenance therapy for severe eosinophilic asthma and treat eosinophilic granulomatosis with polyangiitis (EGPA). It is also being studied in various other eosinophil-driven diseases
GSK R&D president and chief scientific officer Dr Hal Barron said: “HES is a complex, life-threatening condition that impacts nearly 5,000 patients in the US. Today’s approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases.”
Recently, GSK and French pharmaceutical firm Sanofi have entered into an advanced purchase agreement with the European Commission (EC) to supply up to 300 million doses of adjuvanted Covid-19 vaccine.