Data confirm FASENRA’s well-established safety profile consistent with previous Phase III trials
At least 75% of FASENRA-treated patients with elevated blood eosinophil levels had zero exacerbations each year of the open-label period
WILMINGTON, Del.– Results from a new integrated analysis including data from the MELTEMI Phase III open-label extension trial showed FASENRA® (benralizumab) was well-tolerated for up to five years, with a long-term safety profile consistent with previous Phase III trials in adult patients with severe asthma.
Results were presented today at the American Thoracic Society (ATS) 2021 International Conference.
During the period of the BORA and MELTEMI extension trials, adverse events (AEs) and serious adverse events (SAEs) did not increase from rates comparable to placebo observed in the Phase III pivotal trials. Rates of serious infection, hypersensitivity, immunogenicity, and malignancy were low across all treatment groups, with no deaths during the on-treatment window. The most commonly reported AEs during the open-label period for patients receiving FASENRA every eight weeks were nasopharyngitis, asthma, headache, and bronchitis. These data confirm FASENRA’s well-established safety profile.
In secondary endpoints, FASENRA sustained the reduction in asthma exacerbation rates observed during predecessor SIROCCO, CALIMA, ZONDA and BORA Phase III trials with annualized asthma exacerbation rates (AAER) remaining consistently low over the five-year treatment period.
In patients taking high-dosage inhaled corticosteroids (ICS) with blood eosinophil levels of greater than or equal to 300 cells per microliter who received FASENRA every eight weeks, AAER decreased from 3.1 exacerbation/year pre-treatment to 0.5 in the predecessor studies with a further reduction to 0.2 by year four of the open-label trial. In the same treatment group 59% of patients experienced zero exacerbations during the four years of the open-label period (BORA and MELTEMI) and at least 75% of patients each year experienced zero exacerbations. In the final year of the trial 87% of patients experienced zero exacerbations.
Arnaud Bourdin, Head of Pulmonology, Professor of Respiratory Medicine at Arnaud de Villeneuve Hospital, Montpellier, France and primary investigator for MELTEMI, said: “Clinicians treating severe eosinophilic asthma want to ensure the therapy they prescribe will continue to help patients control their illness in the long term, with a consistent safety profile. Based on the new MELTEMI data, physicians and their patients should feel confident that FASENRA provides a treatment option that can do exactly that – reduce exacerbations, with a known safety profile.”
Mark White, Global Franchise Head, FASENRA, said: “The new data from MELTEMI are exciting as they confirm FASENRA’s efficacy and safety profile seen in previously reported Phase III trials. These results should offer further confidence to physicians and patients that the positive outcomes they’re experiencing whilst using FASENRA can be maintained for the longer-term.”
FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries and is approved for self-administration in the US and EU. The Food and Drug Administration (FDA) granted Orphan Drug Designation for FASENRA for eosinophilic granulomatosis with polyangiitis (EGPA) (November 2018), hypereosinophilic syndrome (HES) (February 2019) and eosinophilic oesophagitis (EoE) (August 2019).