New FASENRA® Data Confirm Long-Term Safety and Efficacy in Severe Eosinophilic Asthma Over Five Years

May 19, 2021 /BioonBIOON/ --AstraZeneca(AstraZeneca) recently at the American Thoracic Society (ATS) 2021 InternationalConferenceannounced new results from a comprehensive analysis, including data from the MELTEMI Phase 3 open-label extension trial of the anti-inflammatory drug Fasenra (benralizumab) for the treatment of asthma. The analysis showed that,Fasenra was well tolerated for up to 5 years., long-term safety was consistent with previous Phase 3 trials conducted in adult patients with severe asthma. During the open-label period,Annually, at least 75% of patients with elevated blood eosinophil levels treated with Fasenra did not experienceAsthmaWorsened.

During the BORA and MELTEMI extension trials, the incidence of adverse events (AEs) and serious adverse events (SAEs) with Fasenra compared with placebo did not increase relative to that observed in the pivotal Phase III trials. Serious infections, hypersensitivity reactions, immunogenicity, and malignancies across all treatment groupsTumorAll incidence rates were low, with no deaths reported during the treatment period. During the open-label period, among patients receiving Fasenra once every 8 weeks, the most commonAdverse Reactionsis nasopharyngitis,Asthma, headache and bronchitis. These data confirm the favorable safety profile of Fasenra.

Regarding secondary endpoints, Fasenra maintained the reduction in asthma exacerbation rates observed in the previous Phase III SIROCCO, CALIMA, ZONDA, and BORA trials,During the 5-year treatment period, annualizedAsthmaThe annualized acute exacerbation rate (AAER) has consistently remained at a low level.

Among patients receiving Fasenra every 8 weeks who were maintained on high-dose inhaled corticosteroids (ICS) and had blood eosinophil levels ≥300 cells/μL, the AAER decreased from 3.1 asthma exacerbations per year prior to treatment to 0.5 in a previous study, and further decreased to 0.2 in Year 4 of the open-label trial. In the same treatment group, 59% of patients remained exacerbation-free throughout the 4-year open-label period (BORA and MELTEMI), with at least 75% of patients experiencing no asthma exacerbations annually.In the final year of the trial, 87% of patients did not experienceAsthmaWorsen.

Arnaud Bourdin, Principal Investigator of the MELTEMI study, Professor of Respiratory Medicine and Director of Pulmonology at Arnaud de Villeneuve Hospital in Montpellier, France, stated: “Clinicians treating severe eosinophilic asthma want to ensure that the treatment regimens they prescribe continue to help patients maintain long-term disease control with a consistent safety profile. Based on the latest data from the MELTEMI study, physicians and their patients can be confident that Fasenra provides a treatment regimen that achieves this—reduce...”Asthmaworsen."

Mark White, Global Franchise Lead for Fasenra at AstraZeneca, said: “The new data from the MELTEMI study are exciting, as they confirm the efficacy and safety of Fasenra observed in the previously reported Phase III trials. These results should provide physicians and patients with further confidence that the positive outcomes experienced with Fasenra can be sustained long-term.”

The active pharmaceutical ingredient of Fasenra is benralizumab, a monoclonal antibody that directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) on eosinophils and uniquely recruits natural killer (NK) cells, through`Apoptosis`(Programmed cell death) induces rapid and nearly complete depletion of eosinophils.

Currently, Fasenra has been approved in the United States, the European Union, Japan, and other countries as an add-on maintenance treatment for the treatment of severe eosinophilic...Asthma. Additionally, the Fasenra self-administration option has also been approved in the United States and the European Union for patient self-administration via a new prefilled, single-use autoinjector (Fasenra pen).

Fasenra was licensed to AstraZeneca by BioWa, a wholly owned subsidiary of the Japanese pharmaceutical company Kyowa Hakko Kirin. In late March 2020, AstraZeneca and Kyowa Hakko Kirin signed a new agreement, securing the Asian rights to Fasenra for all indications. In addition to the approved eosinophilicAsthmaBeyond the approved indications, AstraZeneca is also evaluating Fasenra for the treatment of 8 eosinophil-driven diseases, including: severe nasal polyps, eosinophilic esophagitis (EoE), hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), chronic obstructive pulmonary disease (COPD), among others. Previously,FDAOrphan drug designation has been granted to Fasenra for the treatment of EoE, HES, and EGPA. (Bioon.com)

Source: New FASENRA® data from the MELTEMI extension trial confirm long-term safety and efficacy in severe eosinophilic asthma for up to five years